首页 期刊 论文 学科刊群 资讯 加盟 关于
EN
image
Article(id=1292135422491128440, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135402790482407, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.11.011, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1769443200000, receivedDateStr=2026-01-27, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785998691437, onlineDateStr=2026-08-06, pubDate=1781625600000, pubDateStr=2026-06-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785998691437, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785998691437, creator=13701087609, updateTime=1785998691437, updator=13701087609, issue=Issue{id=1292135402790482407, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='11', pageStart='1501', pageEnd='1650', issueExtLink='null', onlineDate='null', pubDate='1781625600000', pubDateStr='2026-06-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=1, specialIssue=null, createTime=1785998686739, creator='13701087609', updateTime=1786014315540, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292200954833686587, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135402790482407, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292200954833686588, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135402790482407, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1567, endPage=1572, ext={EN=ArticleExt(id=1292135422910558841, articleId=1292135422491128440, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=A bioequivalence study of erlotinib hydrochloride tablets in healthy Chinese subjects, columnId=1246531407389020354, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Pharmacokinetics and Bioequivalence Study, runingTitle=null, highlight=null, articleAbstract=
Objective

To analyze the bioequivalence and safety of the test and reference formulations of erlotinib hydrochloride tablets in healthy Chinese subjects under fasting conditions following a single oral dose.

Methods

The study was conducted as a randomized, open-label, two-period crossover trial. A total of 60 healthy subjects were assigned to two sequences by randomization. Under fasting conditions, subjects received a single 150 mg oral dose of either the test or reference formulation, with a 12-day washout period between doses. The plasma concentrations of erlotinib were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS), and the pharmacokinetic parameters were calculated for bioequivalence evaluation using Phoenix WinNonlin software (version 8.3).

Results

After a single oral administration of the test or reference formulation under fasting conditions, the main pharmacokinetic parameters of erlotinib hydrochloride were as follows: maximum concentration (Cmax) was (1 649.48±567.44) and (1 548.15±529.59) ng·mL-1, AUC0-last were (28 830.12±11 507.57) and (29 396.47±11 121.61) h·ng·mL-1, AUC0-inf were (30 759.13±13 789.60) and (31 132.78±12 912.53) h·ng·mL-1. The 90% confidence intervals for the geometric mean ratios of Cmax, AUC0-last, and AUC0-inf for the two formulations were 92.44%-117.31%, 87.65%-103.90% and 87.66%-104.37%, respectively, all of which were within the bioequivalence acceptance range of 80.00%-125.00%. No serious adverse events, suspected unexpected serious adverse reactions, or adverse events leading to withdrawal occurred during the trial.

Conclusion

Under fasting conditions, the test erlotinib hydrochloride tablets were bioequivalent to the reference listed drug Tarceva® in healthy Chinese subjects and the safety profile was favorable.

, authors=Xiu-xin ZHONG1, 2, Shao-jing LIN2, Zi-xin DU2, Xin-yi YANG2, Liu XIAO2, Xian-zhang LIU3, Ling GUAN2, authorsList=Xiu-xin ZHONG, Shao-jing LIN, Zi-xin DU, Xin-yi YANG, Liu XIAO, Xian-zhang LIU, Ling GUAN, authorCompany=null, correspAuthors=Ling GUAN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1292135423355155066, articleId=1292135422491128440, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=盐酸厄洛替尼片在中国健康受试者中的生物等效性研究, columnId=1246531407988805834, journalTitle=中国临床药理学杂志, columnName=药代动力学与生物等效性研究, runingTitle=null, highlight=null, articleAbstract=
目的

评价空腹状态下中国健康受试者单剂口服盐酸厄洛替尼片后，受试与参比制剂的生物等效性及安全性。

方法

用随机、开放、两周期、双交叉设计。60名健康受试者经随机分组后，在各周期空腹条件下单次服用盐酸厄洛替尼片受试或参比制剂150 mg，两次给药间隔12 d。用液相色谱串联质谱法（LC-MS/MS）测定血浆中厄洛替尼的血药浓度，用Phoenix WinNonlin 8.3软件进行药物代谢动力学参数计算及生物等效性评价。

结果

受试者单次空腹口服受试制剂和参比制剂后，盐酸厄洛替尼的主要药物代谢动力学参数如下：达峰浓度（Cmax）分别为（1 649.48±567.44）和（1 548.15±529.59）ng·mL-1，AUC0-last分别为（28 830.12±11 507.57）和（29 396.47±11 121.61）h·ng·mL-1，AUC0-inf分别为（30 759.13±13 789.60）和（31 132.78±12 912.53）h·ng·mL-1。2制剂的Cmax、AUC0-last及AUC0-inf几何均值比的90%置信区间分别为92.44%~117.31%、87.65%~103.90%及87.66%~104.37%，均在80.00%~125.00%的等效区间内。研究期间均未发生严重不良事件、可疑且非预期的严重不良反应及导致脱落的不良事件。

结论

空腹条件下，受试制剂盐酸厄洛替尼片与参比制剂特罗凯®在中国健康受试者体内达到生物等效，安全性良好。

, authors=钟秀欣1, 2, 林绍静2, 杜梓欣2, 杨欣仪2, 肖柳2, 刘贤璋3, 关灵2, authorsList=钟秀欣, 林绍静, 杜梓欣, 杨欣仪, 肖柳, 刘贤璋, 关灵, authorCompany=null, correspAuthors=关灵, authorNote=

钟秀欣（1995-），女，中药师，主要从事药物临床试验方面的工作与研究

, correspAuthorsNote=
关灵，主任药师，硕士生导师 Tel: （0769）28637791 E-mail:
, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=68tJZ+3JcHSi5FdqL0Sv+A==, magXml=bPRi9jQpejcp2YS3EXK9kg==, pdfUrl=null, pdf=Hq5JbxU0rfp5uXPTuIhBEQ==, pdfFileSize=2041460, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=iTXd48CPBOF8Ojq1xwR6OQ==, mapNumber=null, fund=null)}, authors=[Author(id=1292135425427141254, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1292135425548776073, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135425427141254, language=EN, stringName=Xiu-xin ZHONG, firstName=Xiu-xin, middleName=null, lastName=ZHONG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, 2, address=1.The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou 510006, Guangdong Province, China
2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135425615884938, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135425427141254, language=CN, stringName=钟秀欣, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, 2, address=1.广州中医药大学 第二临床医学院，广东 广州 510006
2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059, bio={"content":"

钟秀欣（1995-），女，中药师，主要从事药物临床试验方面的工作与研究

"}, bioImg=null, bioContent=

钟秀欣（1995-），女，中药师，主要从事药物临床试验方面的工作与研究

, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135425158705788, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=1., ext=[AuthorCompanyExt(id=1292135425167094397, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425158705788, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou 510006, Guangdong Province, China), AuthorCompanyExt(id=1292135425175483006, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425158705788, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.广州中医药大学 第二临床医学院，广东 广州 510006)]), AuthorCompany(id=1292135425259369087, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=2., ext=[AuthorCompanyExt(id=1292135425267757696, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China), AuthorCompanyExt(id=1292135425276146305, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059)])]), Author(id=1292135425695576716, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, orderNo=1, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1292135425779462798, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135425695576716, language=EN, stringName=Shao-jing LIN, firstName=Shao-jing, middleName=null, lastName=LIN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135425863348879, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135425695576716, language=CN, stringName=林绍静, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135425259369087, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=2., ext=[AuthorCompanyExt(id=1292135425267757696, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China), AuthorCompanyExt(id=1292135425276146305, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059)])]), Author(id=1292135425922069137, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, orderNo=2, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1292135425997566611, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135425922069137, language=EN, stringName=Zi-xin DU, firstName=Zi-xin, middleName=null, lastName=DU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135426081452692, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135425922069137, language=CN, stringName=杜梓欣, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135425259369087, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=2., ext=[AuthorCompanyExt(id=1292135425267757696, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China), AuthorCompanyExt(id=1292135425276146305, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059)])]), Author(id=1292135426165338774, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, orderNo=3, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1292135426236641944, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135426165338774, language=EN, stringName=Xin-yi YANG, firstName=Xin-yi, middleName=null, lastName=YANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135426312139417, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135426165338774, language=CN, stringName=杨欣仪, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135425259369087, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=2., ext=[AuthorCompanyExt(id=1292135425267757696, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China), AuthorCompanyExt(id=1292135425276146305, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059)])]), Author(id=1292135426383442587, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, orderNo=4, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1292135426463134365, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135426383442587, language=EN, stringName=Liu XIAO, firstName=Liu, middleName=null, lastName=XIAO, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135426521854622, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135426383442587, language=CN, stringName=肖柳, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135425259369087, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=2., ext=[AuthorCompanyExt(id=1292135425267757696, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China), AuthorCompanyExt(id=1292135425276146305, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059)])]), Author(id=1292135426584769184, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, orderNo=5, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1292135426672849570, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135426584769184, language=EN, stringName=Xian-zhang LIU, firstName=Xian-zhang, middleName=null, lastName=LIU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=3, address=3.Guangzhou Keruite Pharmaceutical Co., Ltd., Guangzhou 510530, Guangdong Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135426748347043, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135426584769184, language=CN, stringName=刘贤璋, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=3, address=3.广州科锐特药业有限公司 广东 广州 510530, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135425347449474, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=3., ext=[AuthorCompanyExt(id=1292135425355838083, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425347449474, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.Guangzhou Keruite Pharmaceutical Co., Ltd., Guangzhou 510530, Guangdong Province, China), AuthorCompanyExt(id=1292135425364226692, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425347449474, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.广州科锐特药业有限公司 广东 广州 510530)])]), Author(id=1292135426836427429, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, orderNo=6, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=guanling19692024@163.com, emailSecond=null, emailThird=null, correspondingAuthor=1, authorType=1, ext={EN=AuthorExt(id=1292135426907730599, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135426836427429, language=EN, stringName=Ling GUAN, firstName=Ling, middleName=null, lastName=GUAN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135426979033768, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135426836427429, language=CN, stringName=关灵, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135425259369087, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=2., ext=[AuthorCompanyExt(id=1292135425267757696, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China), AuthorCompanyExt(id=1292135425276146305, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059)])])], keywords=[Keyword(id=1292135427067114153, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, language=EN, orderNo=1, keyword=erlotinib hydrochloride tablets), Keyword(id=1292135427121640106, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, language=EN, orderNo=2, keyword=bioequivalence), Keyword(id=1292135427184554667, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, language=EN, orderNo=3, keyword=pharmacokinetics), Keyword(id=1292135427264246444, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, language=EN, orderNo=4, keyword=healthy subjects), Keyword(id=1292135427423629997, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, language=CN, orderNo=1, keyword=盐酸厄洛替尼片), Keyword(id=1292135427494933166, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, language=CN, orderNo=2, keyword=生物等效性), Keyword(id=1292135427570430639, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, language=CN, orderNo=3, keyword=药物代谢动力学), Keyword(id=1292135427641733808, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, language=CN, orderNo=4, keyword=健康受试者)], refs=null, funds=null, companyList=[AuthorCompany(id=1292135425158705788, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=1., ext=[AuthorCompanyExt(id=1292135425167094397, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425158705788, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou 510006, Guangdong Province, China), AuthorCompanyExt(id=1292135425175483006, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425158705788, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.广州中医药大学 第二临床医学院，广东 广州 510006)]), AuthorCompany(id=1292135425259369087, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=2., ext=[AuthorCompanyExt(id=1292135425267757696, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China), AuthorCompanyExt(id=1292135425276146305, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059)]), AuthorCompany(id=1292135425347449474, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=3., ext=[AuthorCompanyExt(id=1292135425355838083, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425347449474, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.Guangzhou Keruite Pharmaceutical Co., Ltd., Guangzhou 510530, Guangdong Province, China), AuthorCompanyExt(id=1292135425364226692, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425347449474, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.广州科锐特药业有限公司 广东 广州 510530)])], figs=null, attaches=null, journal=Journal(id=1246415058658443328, delFlag=0, nameCn=中国临床药理学杂志, nameEn=Chinese Journal of Clinical Pharmacology, nameHistory1=null, nameHistory2=null, issn=1001-6821, eissn=null, cn=11-2220/R, coden=null, periodic=3, language=CN, oaType=null, ccby=null, superviseOffice=null, ownerOffice=null, pubOffice=null, editorOffice=null, officeType=null, aims=null, clcCode=null, officeProv=null, officeCity=null, officeAddr=null, officeZip=null, officeEmail=null, officePhone=null, editDirector=null, officeDirector=null, officeDirectorPhone=null, officeStaffNum=null, officeEmpNum=null, coverPicUrl=8cEfS7jvj/ukyhKVOMJePA==, journalPrice=null, startedYear=null, abbrevIsoEn=Chinese Journal of Clinical Pharmacology, journalRemark=null, publicationField=null, createdTime=1775098107259, updatedTime=1788948995538, createdBy=18614031015, updatedBy=13041195026, firstLetterCn=Z, firstLetterEn=Z, subjectCode=Medical and Pharmaceutical Sciences, subjectName=null, subjectCodeEn=Medical and Pharmaceutical Sciences, subjectNameEn=null, picCn=8cEfS7jvj/ukyhKVOMJePA==, picEn=cQ12tu98gbNetbFuefeYGg==, jcr=null, cjcr=null, exts=[JournalExt(id=1304509895005466898, language=CN, name=中国临床药理学杂志, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1788948995591, updatedTime=1788948995591, createdBy=13041195026, updatedBy=13041195026, submissionGuidelinesUrl=, submissionAuthorUrl=https://lcylauthor.cast.org.cn/webm, submissionEditorUrl=https://lcyleditor.cast.org.cn/webm, submissionReviewUrl=https://lcylauthor.cast.org.cn/webm, submissionCeEditorUrl=https://lcyleditor.cast.org.cn/webm, submissionAeEditorUrl=https://lcyleditor.cast.org.cn/webm, option={"copyright":""}), JournalExt(id=1304509895047409939, language=EN, name=Chinese Journal of Clinical Pharmacology, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1788948995601, updatedTime=1788948995601, createdBy=13041195026, updatedBy=13041195026, submissionGuidelinesUrl=, submissionAuthorUrl=https://lcylauthor.cast.org.cn/webm, submissionEditorUrl=https://lcyleditor.cast.org.cn/webm, submissionReviewUrl=https://lcylauthor.cast.org.cn/webm, submissionCeEditorUrl=https://lcyleditor.cast.org.cn/webm, submissionAeEditorUrl=https://lcyleditor.cast.org.cn/webm, option={"copyright":""})], databaseList=null, tenantJournalId=1246415772164075586, websiteList=[Website(id=1246421196657546140, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1246415772164075586, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/zglcylxzz/CN, language=CN, createTime=1775099570670, createBy=18614031015, updateTime=1775099747371, updateBy=18614031015, name=中国临床药理学杂志-中文, tplId=1146099689490845704, title=中国临床药理学杂志, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1246422027293316008, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=articleTextType, value=kx, createTime=1775099768708, updateTime=1775099768708, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027268150181, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=banner, value=null, createTime=1775099768702, updateTime=1775099768702, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027310093227, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=grayFlag, value=0, createTime=1775099768712, updateTime=1775099768712, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027259761572, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=logo, value=https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/file/pic?fileId=KeUk4pyVjfIIkOq40uZX0Q==, createTime=1775099768700, updateTime=1775099768700, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027322676141, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=minRunFlag, value=0, createTime=1775099768715, updateTime=1775099768715, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027284927399, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/file/pic, createTime=1775099768706, updateTime=1775099768706, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027318481836, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=silenceFlag, value=0, createTime=1775099768714, updateTime=1775099768714, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027276538790, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_cn_619/, createTime=1775099768704, updateTime=1775099768704, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027297510313, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=themeColor, value=null, createTime=1775099768709, updateTime=1775099768709, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422027305898922, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196657546140, code=themeStyle, value=null, createTime=1775099768711, updateTime=1775099768711, creator=18614031015, updator=18614031015)]), Website(id=1246421196871455649, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1246415772164075586, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/zglcylxzz/EN, language=EN, createTime=1775099570720, createBy=18614031015, updateTime=1775099757298, updateBy=18614031015, name=中国临床药理学杂志-英文, tplId=1146101810881728533, title=Chinese Journal of Clinical Pharmacology, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1246422058998059954, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=articleTextType, value=kx, createTime=1775099776267, updateTime=1775099776267, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422058977088431, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=banner, value=null, createTime=1775099776262, updateTime=1775099776262, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422059014837173, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=grayFlag, value=0, createTime=1775099776271, updateTime=1775099776271, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422058968699822, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=logo, value=https://castjournals.cast.org.cn/joweb/zglcylxzz/EN/file/pic?fileId=KeUk4pyVjfIIkOq40uZX0Q==, createTime=1775099776260, updateTime=1775099776260, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422059031614391, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=minRunFlag, value=0, createTime=1775099776275, updateTime=1775099776275, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422058993865649, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/zglcylxzz/EN/file/pic, createTime=1775099776266, updateTime=1775099776266, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422059023225782, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=silenceFlag, value=0, createTime=1775099776273, updateTime=1775099776273, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422058985477040, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_en_623/, createTime=1775099776264, updateTime=1775099776264, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422059002254259, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=themeColor, value=null, createTime=1775099776268, updateTime=1775099776268, creator=18614031015, updator=18614031015), WebsiteProps(id=1246422059010642868, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1246421196871455649, code=themeStyle, value=null, createTime=1775099776270, updateTime=1775099776270, creator=18614031015, updator=18614031015)])], journalTitle=中国临床药理学杂志, weixinUrl=null, journalUrl=null, iacademicId=null, status=1, seqNo=null, journalTitleEn=Chinese Journal of Clinical Pharmacology, journalPhotoCn=8cEfS7jvj/ukyhKVOMJePA==, journalPhotoEn=cQ12tu98gbNetbFuefeYGg==, journalFirstLetter=Z, journalRecommend=null, journalNew=null, journalCollection=null, jcrJf=null, cjcrJf=null, jcrJfStr=null, cjcrJfStr=null, submissionFirstDecision=null, sciSubjectClassification=null, casSubjectClassification=null, citeScore=null, totalCitationFrequency=null, icpCode=null, psCode=null, advertisingLicenseCode=null, copyrightInformation=null, country=null, option=, provinceCode=null, provinceName=null, collectFlag=false, interPubPlatform=, interPubPlatformUrl=null), detailUrlCn=https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2026.11.011, detailUrlEn=https://castjournals.cast.org.cn/joweb/zglcylxzz/EN/10.13699/j.cnki.1001-6821.2026.11.011, pdfUrlCn=https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/PDF/10.13699/j.cnki.1001-6821.2026.11.011, pdfUrlEn=https://castjournals.cast.org.cn/joweb/zglcylxzz/EN/PDF/10.13699/j.cnki.1001-6821.2026.11.011, aliStartDate=0, aliEndDate=0, collectionFlag=false, citedCount=null, citedUrl=null, previewStatus=0, delFlag=0, hasFullText=0, orderTime=1781625600000, fullTextJson=null, articleText=null, reference=null)
收藏切换
盐酸厄洛替尼片在中国健康受试者中的生物等效性研究
收藏切换
PDF下载
钟秀欣 1, 2 , 林绍静 2 , 杜梓欣 2 , 杨欣仪 2 , 肖柳 2 , 刘贤璋 3 , 关灵 2
中国临床药理学杂志 | 药代动力学与生物等效性研究 2026,42(11): 1567-1572
收起
收藏切换
中国临床药理学杂志 |药代动力学与生物等效性研究 2026 , 42 (11) : 1567 -1572
盐酸厄洛替尼片在中国健康受试者中的生物等效性研究
全屏
[Author(id=1292135425427141254, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1292135425548776073, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135425427141254, language=EN, stringName=Xiu-xin ZHONG, firstName=Xiu-xin, middleName=null, lastName=ZHONG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, 2, address=1.The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou 510006, Guangdong Province, China
2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135425615884938, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135425427141254, language=CN, stringName=钟秀欣, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, 2, address=1.广州中医药大学 第二临床医学院，广东 广州 510006
2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059, bio={"content":"

钟秀欣（1995-），女，中药师，主要从事药物临床试验方面的工作与研究

"}, bioImg=null, bioContent=

钟秀欣（1995-），女，中药师，主要从事药物临床试验方面的工作与研究

, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135425158705788, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=1., ext=[AuthorCompanyExt(id=1292135425167094397, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425158705788, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou 510006, Guangdong Province, China), AuthorCompanyExt(id=1292135425175483006, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425158705788, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.广州中医药大学 第二临床医学院，广东 广州 510006)]), AuthorCompany(id=1292135425259369087, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=2., ext=[AuthorCompanyExt(id=1292135425267757696, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China), AuthorCompanyExt(id=1292135425276146305, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059)])]), Author(id=1292135425695576716, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, orderNo=1, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1292135425779462798, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135425695576716, language=EN, stringName=Shao-jing LIN, firstName=Shao-jing, middleName=null, lastName=LIN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135425863348879, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135425695576716, language=CN, stringName=林绍静, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135425259369087, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=2., ext=[AuthorCompanyExt(id=1292135425267757696, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China), AuthorCompanyExt(id=1292135425276146305, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059)])]), Author(id=1292135425922069137, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, orderNo=2, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1292135425997566611, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135425922069137, language=EN, stringName=Zi-xin DU, firstName=Zi-xin, middleName=null, lastName=DU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135426081452692, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135425922069137, language=CN, stringName=杜梓欣, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135425259369087, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=2., ext=[AuthorCompanyExt(id=1292135425267757696, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China), AuthorCompanyExt(id=1292135425276146305, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059)])]), Author(id=1292135426165338774, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, orderNo=3, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1292135426236641944, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135426165338774, language=EN, stringName=Xin-yi YANG, firstName=Xin-yi, middleName=null, lastName=YANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135426312139417, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135426165338774, language=CN, stringName=杨欣仪, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135425259369087, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=2., ext=[AuthorCompanyExt(id=1292135425267757696, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China), AuthorCompanyExt(id=1292135425276146305, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059)])]), Author(id=1292135426383442587, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, orderNo=4, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1292135426463134365, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135426383442587, language=EN, stringName=Liu XIAO, firstName=Liu, middleName=null, lastName=XIAO, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135426521854622, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135426383442587, language=CN, stringName=肖柳, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135425259369087, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=2., ext=[AuthorCompanyExt(id=1292135425267757696, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China), AuthorCompanyExt(id=1292135425276146305, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059)])]), Author(id=1292135426584769184, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, orderNo=5, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1292135426672849570, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135426584769184, language=EN, stringName=Xian-zhang LIU, firstName=Xian-zhang, middleName=null, lastName=LIU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=3, address=3.Guangzhou Keruite Pharmaceutical Co., Ltd., Guangzhou 510530, Guangdong Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135426748347043, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135426584769184, language=CN, stringName=刘贤璋, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=3, address=3.广州科锐特药业有限公司 广东 广州 510530, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135425347449474, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=3., ext=[AuthorCompanyExt(id=1292135425355838083, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425347449474, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.Guangzhou Keruite Pharmaceutical Co., Ltd., Guangzhou 510530, Guangdong Province, China), AuthorCompanyExt(id=1292135425364226692, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425347449474, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.广州科锐特药业有限公司 广东 广州 510530)])]), Author(id=1292135426836427429, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, orderNo=6, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=guanling19692024@163.com, emailSecond=null, emailThird=null, correspondingAuthor=1, authorType=1, ext={EN=AuthorExt(id=1292135426907730599, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135426836427429, language=EN, stringName=Ling GUAN, firstName=Ling, middleName=null, lastName=GUAN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1292135426979033768, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, authorId=1292135426836427429, language=CN, stringName=关灵, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=2, address=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1292135425259369087, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, xref=2., ext=[AuthorCompanyExt(id=1292135425267757696, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China), AuthorCompanyExt(id=1292135425276146305, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1292135422491128440, companyId=1292135425259369087, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059)])])]
钟秀欣1, 2, 林绍静2, 杜梓欣2, 杨欣仪2, 肖柳2, 刘贤璋3, 关灵2
作者信息
  • 1.广州中医药大学 第二临床医学院，广东 广州 510006
  • 2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059
  • 3.广州科锐特药业有限公司 广东 广州 510530
通讯作者:
关灵，主任药师，硕士生导师 Tel: （0769）28637791 E-mail:
作者简介:

钟秀欣（1995-），女，中药师，主要从事药物临床试验方面的工作与研究

A bioequivalence study of erlotinib hydrochloride tablets in healthy Chinese subjects
Xiu-xin ZHONG1, 2, Shao-jing LIN2, Zi-xin DU2, Xin-yi YANG2, Liu XIAO2, Xian-zhang LIU3, Ling GUAN2
Affiliations
  • 1.The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou 510006, Guangdong Province, China
  • 2.The Tenth Affiliated Hospital, Southern Medical University/Dongguan People’s Hospital, Dongguan 523059, Guangdong Province, China
  • 3.Guangzhou Keruite Pharmaceutical Co., Ltd., Guangzhou 510530, Guangdong Province, China
出版时间: 2026-06-17 doi: 10.13699/j.cnki.1001-6821.2026.11.011
文章导航
收藏切换
摘要
收起
目的

评价空腹状态下中国健康受试者单剂口服盐酸厄洛替尼片后，受试与参比制剂的生物等效性及安全性。

方法

用随机、开放、两周期、双交叉设计。60名健康受试者经随机分组后，在各周期空腹条件下单次服用盐酸厄洛替尼片受试或参比制剂150 mg，两次给药间隔12 d。用液相色谱串联质谱法（LC-MS/MS）测定血浆中厄洛替尼的血药浓度，用Phoenix WinNonlin 8.3软件进行药物代谢动力学参数计算及生物等效性评价。

结果

受试者单次空腹口服受试制剂和参比制剂后，盐酸厄洛替尼的主要药物代谢动力学参数如下：达峰浓度（Cmax）分别为（1 649.48±567.44）和（1 548.15±529.59）ng·mL-1，AUC0-last分别为（28 830.12±11 507.57）和（29 396.47±11 121.61）h·ng·mL-1，AUC0-inf分别为（30 759.13±13 789.60）和（31 132.78±12 912.53）h·ng·mL-1。2制剂的Cmax、AUC0-last及AUC0-inf几何均值比的90%置信区间分别为92.44%~117.31%、87.65%~103.90%及87.66%~104.37%，均在80.00%~125.00%的等效区间内。研究期间均未发生严重不良事件、可疑且非预期的严重不良反应及导致脱落的不良事件。

结论

空腹条件下，受试制剂盐酸厄洛替尼片与参比制剂特罗凯®在中国健康受试者体内达到生物等效，安全性良好。

盐酸厄洛替尼片  /  生物等效性  /  药物代谢动力学  /  健康受试者
Objective

To analyze the bioequivalence and safety of the test and reference formulations of erlotinib hydrochloride tablets in healthy Chinese subjects under fasting conditions following a single oral dose.

Methods

The study was conducted as a randomized, open-label, two-period crossover trial. A total of 60 healthy subjects were assigned to two sequences by randomization. Under fasting conditions, subjects received a single 150 mg oral dose of either the test or reference formulation, with a 12-day washout period between doses. The plasma concentrations of erlotinib were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS), and the pharmacokinetic parameters were calculated for bioequivalence evaluation using Phoenix WinNonlin software (version 8.3).

Results

After a single oral administration of the test or reference formulation under fasting conditions, the main pharmacokinetic parameters of erlotinib hydrochloride were as follows: maximum concentration (Cmax) was (1 649.48±567.44) and (1 548.15±529.59) ng·mL-1, AUC0-last were (28 830.12±11 507.57) and (29 396.47±11 121.61) h·ng·mL-1, AUC0-inf were (30 759.13±13 789.60) and (31 132.78±12 912.53) h·ng·mL-1. The 90% confidence intervals for the geometric mean ratios of Cmax, AUC0-last, and AUC0-inf for the two formulations were 92.44%-117.31%, 87.65%-103.90% and 87.66%-104.37%, respectively, all of which were within the bioequivalence acceptance range of 80.00%-125.00%. No serious adverse events, suspected unexpected serious adverse reactions, or adverse events leading to withdrawal occurred during the trial.

Conclusion

Under fasting conditions, the test erlotinib hydrochloride tablets were bioequivalent to the reference listed drug Tarceva® in healthy Chinese subjects and the safety profile was favorable.

erlotinib hydrochloride tablets  /  bioequivalence  /  pharmacokinetics  /  healthy subjects
钟秀欣, 林绍静, 杜梓欣, 杨欣仪, 肖柳, 刘贤璋, 关灵. 盐酸厄洛替尼片在中国健康受试者中的生物等效性研究. 中国临床药理学杂志, 2026 , 42 (11) : 1567 -1572 . DOI: 10.13699/j.cnki.1001-6821.2026.11.011
Xiu-xin ZHONG, Shao-jing LIN, Zi-xin DU, Xin-yi YANG, Liu XIAO, Xian-zhang LIU, Ling GUAN. A bioequivalence study of erlotinib hydrochloride tablets in healthy Chinese subjects[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (11) : 1567 -1572 . DOI: 10.13699/j.cnki.1001-6821.2026.11.011

文献
收起
参考文献 引证文献
排序方式：
2026年第42卷第11期
PDF下载
201
32
引用本文
BibTeX
文章信息
doi: 10.13699/j.cnki.1001-6821.2026.11.011
  • 接收时间：2026-01-27
  • 首发时间：2026-08-06
  • 出版时间：2026-06-17
补充材料
相关文章
文章信息
作者
出版历史
  • 收稿日期：2026-01-27
基金
作者信息
    1.广州中医药大学 第二临床医学院，广东 广州 510006
    2.南方医科大学 第十附属医院/东莞市人民医院，广东 东莞 523059
    3.广州科锐特药业有限公司 广东 广州 510530

通讯作者:

关灵，主任药师，硕士生导师 Tel: （0769）28637791 E-mail:
参考文献
分享链接
https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2026.11.011
分享至
全文二维码

扫描看全文

引用本文
BibTeX
本文的引用情况
2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
关闭全屏
相关链接
论文
最新文章
热读文章
热点专题
内参
蓝皮书
产业发展报告
传播力报告
期刊分级目录
资讯
学术新闻
行业新闻
学术会议
行业会议
关于
关于我们
联系我们
北京市海淀区学院南路86号
100081
010-62199257（仅加盟咨询）
qkjq@cast.org.cn

中国科学技术协会版权所有 京ICP 备10216604号-4 海淀分局备案 1101084647
科技导报社主办 中国科协信息中心技术支持