Article(id=1291404328074469430, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404284806030089, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.04.019, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1721923200000, receivedDateStr=2024-07-26, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824384944, onlineDateStr=2026-08-04, pubDate=1740672000000, pubDateStr=2025-02-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824384944, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824384944, creator=13701087609, updateTime=1785824384944, updator=13701087609, issue=Issue{id=1291404284806030089, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='4', pageStart='451', pageEnd='600', issueExtLink='null', onlineDate='null', pubDate='1740672000000', pubDateStr='2025-02-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824374629, creator='13701087609', updateTime=1785824374629, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=543, endPage=547, ext={EN=ArticleExt(id=1291404328477122615, articleId=1291404328074469430, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Bioequivalence study of montelukast sodium chewable tablets in Chinese healthy subjects, columnId=1246531407389020354, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Pharmacokinetics and Bioequivalence Study, runingTitle=null, highlight=null, articleAbstract=
Objective To evaluate the bioequivalence of montelukast sodium chewable tablets test formulation and reference formulation in Chinese healthy subjects.
Methods A single-center, single-dose, two-period, randomized, open-label, self-cross-over design was designed. A single oral dose of montelukast sodium chewable tablets 5 mg was administered under fasting or fed conditions in each period. The blood concentration of montelukast in plasma was determined by liquid chromatography-mass spectrometry, and pharmacokinetic parameters were calculated by SAS 9.4 software.
Results Twenty-six and 30 cases healthy subjects were included in the fasting and fed groups, respectively. The main pharmacokinetics (PK) parameters of the test formulation and reference formulation in the fasting group: Cmax were (331.00±86.00) and (327.08±76.03) ng·mL-1; AUC0-t were (2 265.12±560.34) and (2 318.56±589.51) ng·mL-1·h; AUC0-∞ were (2 352.60±591.43) and (2 409.12±636.79) ng·mL-1·h, respectively. The main PK parameters of the test formulation and reference formulation in the fed group: Cmax were (262.07±52.94) and (256.73±63.07) ng·mL-1; AUC0-t were (2 014.43±356.47) and (2 071.53±462.56) ng·mL-1·h; AUC0-∞ were (2 072.30±384.30) and (2 138.57±509.46) ng·mL-1·h, respectively. The 90% confidence intervals of the geometric mean ratios of the main PK parameters of montelukast in the test formulation and reference formulation in fasting and fed groups were all within 80.00%-125.00%. In the fasting test, a total of 8 cases (32.00%) subjects had 11 adverse reactions, and in the fed test, a total of 11 cases (36.67%) subjects had 18 adverse reactions.
Conclusion The test and reference montelukast sodium chewable tablets were bioequivalent under fasting and fed conditions.
, authors=Li-ping SHI
1, Fang LIU
1, Jun ZHANG
1, Jun-gang YIN
1, Jing-mei YU
1, Ke-li WAGN
2, Chong ZOU
1, authorsList=Li-ping SHI, Fang LIU, Jun ZHANG, Jun-gang YIN, Jing-mei YU, Ke-li WAGN, Chong ZOU, authorCompany=null, correspAuthors=Chong ZOU, 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=1291404329030770744, articleId=1291404328074469430, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=孟鲁司特钠咀嚼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 评价孟鲁司特钠咀嚼片受试制剂和参比制剂在中国健康受试者体内的生物等效性。
方法 用单中心、单剂量、双周期、随机、开放、自身交叉设计的研究设计。每周期空腹或餐后条件下单次口服孟鲁司特钠咀嚼片5 mg。用液相色谱-质谱法测定血浆中孟鲁司特的血药浓度，用SAS 9.4软件计算药代动力学参数。
结果 空腹组和餐后组分别入组26例和30例健康受试者。空腹组受试制剂与参比制剂的主要药代动力学（PK）参数：Cmax分别为（331.00±86.00）和（327.08±76.03）ng·mL-1，AUC0-t分别为（2 265.12±560.34）和（2 318.56±589.51）ng·mL-1·h，AUC0-∞分别为（2 352.60±591.43）和（2 409.12±636.79）ng·mL-1·h。餐后组受试制剂与参比制剂的主要PK参数：Cmax分别为（262.07±52.94）和（256.73±63.07）ng·mL-1，AUC0-t分别为（2 014.43±356.47）和（2 071.53±462.56）ng·mL-1·h，AUC0-∞分别为（2 072.30±384.30）和（2 138.57±509.46）ng·mL-1·h。空腹组和餐后组孟鲁司特受试制剂与参比制剂的主要PK参数的几何均值比值的90%置信区间均在80.00%~125.00%。空腹组共8例（32.00%）受试者发生11例次药物不良反应，餐后组共11例（36.67%）受试者发生18例次药物不良反应。
结论 孟鲁司特钠咀嚼片受试制剂和参比制剂在空腹和餐后条件下具有生物等效性。
, authors=史丽萍
1, 刘芳
1, 张军
1, 殷俊刚
1, 俞景梅
1, 王可莉
2, 邹冲
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史丽萍（1985-），女，主治医师，主要从事临床试验管理及临床药理试验相关工作
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2.Nanjing Jiening Pharmaceutical Technology Co. Ltd., Nanjing 211100, Jiangsu Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1291404332168110172, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291404328074469430, authorId=1291404331740291161, language=CN, stringName=王可莉, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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