Article(id=1292130360956052323, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130254689165893, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.05.016, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1753718400000, receivedDateStr=2025-07-29, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997484672, onlineDateStr=2026-08-06, pubDate=1773676800000, pubDateStr=2026-03-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997484672, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997484672, creator=13701087609, updateTime=1785997484672, updator=13701087609, issue=Issue{id=1292130254689165893, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='5', pageStart='601', pageEnd='750', issueExtLink='null', onlineDate='null', pubDate='1773676800000', pubDateStr='2026-03-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785997459337, creator='13701087609', updateTime=1786014469153, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201599108141219, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130254689165893, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201599108141220, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130254689165893, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=700, endPage=705, ext={EN=ArticleExt(id=1292130361178350436, articleId=1292130360956052323, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Bioequivalence study of agomelatine tablets biosimilars in Chinese healthy volunteers, columnId=1246531407389020354, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Pharmacokinetics and Bioequivalence Study, runingTitle=null, highlight=null, articleAbstract=
Objective To evaluate the safety and bioequivalence of two formulations of agomelatine tablets in healthy Chinese subjects.
Methods A randomized, open-label, two-treatment, four-period, two-sequence, fully replicated crossover bioequivalence study was conducted under both fasting and fed conditions. Each subject received a single 25 mg dose of the test (T) product or reference (R) product agomelatine tablet in both fasting and fed conditions. Plasma concentration of agomelatine was determined by the liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The main pharmacokinetic parameters were derived using WinNonlin 8.3 software.
Results A total of 128 subjects were enrolled, 64 in the fasting group and 64 in the fed group. The primary pharmacokinetic(PK) parameters of the test and reference formulations under fasting condition were as follows: Cmax were (25.55±29.65) and (26.59±28.04) ng·mL-1, AUC0-t were (28.59±26.66) and (29.33±26.98) ng·h·mL-1, AUC0-∞ were (29.13±26.96) and (29.62±27.17) ng·h·mL-1. The primary pharmacokinetic parameters of the test and reference formulations under fed condition were as follows: Cmax were (26.26±23.29) and (28.97±34.82) ng·mL-1, AUC0-t were (35.75±27.67) and (36.91±32.59) ng·h·mL-1, AUC0-∞ were (36.15±27.89) and (37.14±32.69) ng·h·mL-1. Under both fasting and post-meal conditions, the 90% confidence interval of the geometric mean ratio (GMR) of the main PK parameters of the test formulation of agomelatine tablets compared to the reference formulation fell within the range of 80%-125%.
Conclusion The test formulations and reference formulations of agomelatine are bioequivalent under both fasting and fed conditions.
, authors=Yan-xia XIAO
1, Ruo-ming LI
1, Shao-jie YANG
1, Gui-gang YANG
1, Ying-zi PEI
2, Xiao ZHAO
2, Yun-long TAN
1, Song CHEN
1, authorsList=Yan-xia XIAO, Ruo-ming LI, Shao-jie YANG, Gui-gang YANG, Ying-zi PEI, Xiao ZHAO, Yun-long TAN, Song CHEN, authorCompany=null, correspAuthors=Yun-long TAN, Song CHEN, 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=1292130361413231461, articleId=1292130360956052323, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=阿戈美拉汀片在中国健康参与者中的生物等效性评价, 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2种阿戈美拉汀片在中国健康参与者中的安全性及生物等效性。
方法 空腹及餐后条件下，按随机、开放、四周期、双序列、完全重复交叉的临床试验设计。参与者在每个周期单次服用阿戈美拉汀片受试制剂或参比制剂25 mg。血浆中阿戈美拉汀的浓度用液相色谱-串联质谱法（LC-MS/MS）测定，主要药代动力学（PK）参数用Phoenix WinNonlin 8.3软件计算。
结果 共128例参与者参与研究，空腹组和餐后组分别入组64例。空腹条件下，受试制剂和参比制剂的主要PK参数：Cmax分别为（25.55±29.65）和（26.59±28.04）ng·mL-1，AUC0-t分别为（28.59±26.66）和（29.33±26.98）ng·h·mL-1，AUC0-∞分别为（29.13±26.96）和（29.62±27.17）ng·h·mL-1。餐后条件下，受试制剂和参比制剂的主要PK参数：Cmax分别为（26.26±23.29）和（28.97±34.82）ng·mL-1，AUC0-t分别为（35.75±27.67）和（36.91±32.59）ng·h·mL-1，AUC0-∞分别为（36.15±27.89）和（37.14±32.69）ng·h·mL-1。空腹及餐后2种条件下，阿戈美拉汀片受试制剂与参比制剂主要PK参数的几何均值比值（GMR）的90%置信区间均落在80%~125％。
结论 空腹及餐后条件下，阿戈美拉汀片的受试制剂和参比制剂具有生物等效性。
, authors=肖艳霞
1, 李若茗
1, 杨少杰
1, 杨贵刚
1, 裴莹子
2, 赵晓
2, 谭云龙
1, 陈松
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