Article(id=1291404820401877130, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404791758975909, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.11.017, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1734364800000, receivedDateStr=2024-12-17, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824502324, onlineDateStr=2026-08-04, pubDate=1750089600000, pubDateStr=2025-06-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824502324, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824502324, creator=13701087609, updateTime=1785824502324, updator=13701087609, issue=Issue{id=1291404791758975909, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='11', pageStart='1501', pageEnd='1650', issueExtLink='null', onlineDate='null', pubDate='1750089600000', pubDateStr='2025-06-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824495496, creator='13701087609', updateTime=1785824495496, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=1595, endPage=1601, ext={EN=ArticleExt(id=1291404820942942347, articleId=1291404820401877130, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Bioequivalence study of trifluridine/tipiracil tablet in Chinese solid tumor patients, columnId=1246531407389020354, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Pharmacokinetics and Bioequivalence Study, runingTitle=null, highlight=null, articleAbstract=
Objective To investigate the pharmacokinetic characteristics, safety and tolerability of single oral administration of trifluridine/tipiracil tablet in Chinese solid tumors under fasting and fed states, to evaluate the bioequivalence of the two formulations.
Methods A randomized, open-label, two-formulation, two-sequence, four-cycle, repeated crossover design was used, with 30 subjects enrolled in both the fasting and fed groups, receiving a single oral dose of 60 mg of the test or reference formulation in each cycle. The concentrations of trifluridine and tipiracil in plasma were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Phoenix WinNonlin 8.3 and SAS 9.4 software were used for pharmacokinetic parameter and bioequivalence analysis.
Results Fasting group: The pharmacokinetic parameters of trifluridine were as follows. For the test preparation, Cmax was (6 711.36±1 641.92) ng·mL-1; AUC0-t was (14 216.19±4 420.98) h·ng·mL-1; AUC0-∞ was (14 432.88±4 613.02) h·ng·mL-1. For the reference preparation, Cmax was (6 332.20±1 606.03) ng·mL-1; AUC0-t was (14 393.26±4 070.13) h·ng·mL-1; AUC0-∞ was (14 636.58±4 285.74) h·ng·mL-1. The pharmacokinetic parameters of tipiracil were as follows. For the test preparation, Cmax was (140.73±44.39) ng·mL-1; AUC0-t was (491.99±149.66) h·ng·mL-1; AUC0-∞ was (499.49±150.62) h·ng·mL-1. For the reference preparation, Cmax was (142.70±42.64) ng·mL-1; AUC0-t was (505.43±135.58) h·ng·mL-1; AUC0-∞ was (513.42±137.70) h·ng·mL-1. Fed group: The pharmacokinetic parameters of trifluridine were as follows. For the test preparation, Cmax was (3 703.22±875.59) ng·mL-1; AUC0-t was (10 817.63±3 466.63) h·ng·mL-1; AUC0-∞ was (10 986.12±3 776.68) h·ng·mL-1. For the reference preparation, Cmax was (3 754.66±915.72) ng·mL-1; AUC0-t was (10 775.42±3 594.37) h·ng·mL-1; AUC0-∞ was (11 002.36±4 106.89) h·ng·mL-1. The pharmacokinetic parameters of tipiracil were as follows. For the test preparation, Cmax was (53.73±16.72) ng·mL-1; AUC0-t was (219.63±74.00) h·ng·mL-1; AUC0-∞ was (226.61±77.00) h·ng·mL-1. For the reference preparation, Cmax was (54.73±14.42) ng·mL-1; AUC0-t was (224.66±75.23) h·ng·mL-1; AUC0-∞ was (231.91±78.74) h·ng·mL-1. The geometric mean ratios and their 90% confidence intervals for the main pharmacokinetic parameters (Cmax, AUC0-t, AUC0-∞) of the test and reference formulations of trifluridine/tipiracil were all within the range of 80.00%-125.00%. Common adverse drug reactions in the fasting group includes sinus bradycardia and elevated alanine aminotransferase, while common adverse drug reactions in the fed group included decreased lymphocyte count and detection of urinary sediment. The incidence of adverse drug reactions in the fasting and fed conditions were 36.67% (11 cases / 30 cases) and 46.67% (14 cases / 30 cases), respectively. There were no serious adverse events occurred during the trials in the both group.
Conclusion The test and reference formulations of trifluridine/tipiracil tablet are bioequivalent under both fasting and fed conditions, with good safety and tolerability.
, authors=Li-zhen ZHANG
1, Chao-yang ZHANG
2a, Shuai-bing LIU
1, Wen-hua XUE
1, Lei QI
1, Rui-juan LIU
1, Su-ke SUN
1, Hong-tao LI
2b, Huan ZHOU
2a, Xin TIAN
1, authorsList=Li-zhen ZHANG, Chao-yang ZHANG, Shuai-bing LIU, Wen-hua XUE, Lei QI, Rui-juan LIU, Su-ke SUN, Hong-tao LI, Huan ZHOU, Xin TIAN, authorCompany=null, correspAuthors=Xin TIAN, 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=1291404821353984140, articleId=1291404820401877130, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=曲氟尿苷替匹嘧啶片在中国实体瘤患者中的生物等效性试验, 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 考察空腹和餐后状态下单次口服曲氟尿苷替匹嘧啶片在中国实体瘤患者中的药代动力学特征、安全性和耐受性，评价两制剂的生物等效性。
方法 用随机、开放、两制剂、两序列、四周期、重复交叉设计，空腹和餐后组分别纳入30例受试者，每周期单次口服受试制剂或参比制剂60 mg。用液相色谱-串联质谱（LC-MS / MS）法测定血浆中曲氟尿苷和替匹嘧啶浓度。用Phoenix WinNonlin 8.3软件和SAS 9.4软件进行药代动力学参数及生物等效性分析。
结果 在空腹组中，曲氟尿苷的药代动力学参数分别为受试制剂的Cmax为（6 711.36±1 641.92）ng·mL-1，AUC0-t为（14 216.19±4 420.98）h·ng·mL-1，AUC0-∞为（14 432.88±4 613.02）h·ng·mL-1，参比制剂的Cmax为（6 332.20±1 606.03）ng·mL-1，AUC0-t为（14 393.26±4 070.13）h·ng·mL-1，AUC0-∞为（14 636.58±4 285.74）h·ng·mL-1；替匹嘧啶的药代动力学参数分别为受试制剂的Cmax为（140.73±44.39）ng·mL-1，AUC0-t为（491.99±149.66）h·ng·mL-1，AUC0-∞为（499.49±150.62）h·ng·mL-1，参比制剂的Cmax为（142.70±42.64）ng·mL-1，AUC0-t为（505.43±135.58）h·ng·mL-1，AUC0-∞为（513.42±137.70）h·ng·mL-1。在餐后组中，曲氟尿苷的药代动力学参数分别为受试制剂的Cmax为（3 703.22±875.59）ng·mL-1，AUC0-t为（10 817.63±3 466.63）h·ng·mL-1，AUC0-∞为（10 986.12±3 776.68）h·ng·mL-1，参比制剂的Cmax为（3 754.66±915.72）ng·mL-1，AUC0-t为（10 775.42±3 594.37）h·ng·mL-1，AUC0-∞为（11 002.36±4 106.89）h·ng·mL-1；替匹嘧啶的药代动力学参数分别为受试制剂的Cmax为（53.73±16.72）ng·mL-1，AUC0-t为（219.63±74.00）h·ng·mL-1，AUC0-∞为（226.61±77.00）h·ng·mL-1，参比制剂的Cmax为（54.73±14.42）ng·mL-1，AUC0-t为（224.66±75.23）h·ng·mL-1，AUC0-∞为（231.91±78.74）h·ng·mL-1。空腹和餐后状态下2组Cmax、AUC0-t和AUC0-∞几何均值比值及其90%置信区间均在80.00% ~ 125.00%。空腹组常见的药物不良反应有窦性心动过缓和谷丙转氨酶升高等，餐后组常见的药物不良反应有淋巴细胞计数降低和尿沉渣检出等；空腹和餐后试验药物不良反应发生率分别为36.67%（11例/30例）和46.67%（14例/30例），2组均未发生严重药物不良反应。
结论 曲氟尿苷替匹嘧啶片受试制剂和参比制剂在空腹和餐后状态下均具有生物等效性，其安全性和耐受性良好。
, authors=张丽珍
1, 张朝阳
2a, 刘帅兵
1, 薛文华
1, 齐蕾
1, 刘瑞娟
1, 孙素珂
1, 李洪涛
2b, 周焕
2a, 田鑫
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张丽珍（1990-），女，硕士，主管药师，主要从事临床药理学的相关研究
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2a.蚌埠医科大学 第一附属医院，临床研究中心，安徽 蚌埠 233004, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1291404823186894992, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291404820401877130, xref=2a., ext=[AuthorCompanyExt(id=1291404823195283601, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291404820401877130, companyId=1291404823186894992, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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