Article(id=1291404317253161638, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404284806030089, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.04.017, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1723651200000, receivedDateStr=2024-08-15, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824382365, onlineDateStr=2026-08-04, pubDate=1740672000000, pubDateStr=2025-02-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824382365, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824382365, creator=13701087609, updateTime=1785824382365, 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=533, endPage=537, ext={EN=ArticleExt(id=1291404317475459751, articleId=1291404317253161638, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Bioequivalence study of duloxetine hydrochloride enteric-coated 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 evaluate the bioequivalence of domestic duloxetine hydrochloride enteric-coated tablets and original enteric-coated capsules in Chinese healthy subjects.
Methods In a random, open, two periods, two sequence, self-crossover study, 40 cases healthy subjects in fasting test and 48 cases healthy subjects in fed test were given single oral test preparation and reference preparation 20 mg of duloxetine hydrochloride. The concentrations of duloxetine hydrochloride in plasma were determined by high performance liquid chromatography tandem mass spectrometry. The pharmacokinetic parameters were calculated using Phonenix WinNolin 8.0 software, and the bioequivalence of the test and the reference duloxetine hydrochloride was evaluated.
Results The main pharmacokinetic parameters of the test and the reference duloxetine hydrochloride in fasting test were as follows: Cmax were (16.70±5.94) and (16.70±7.10) ng·mL-1; AUC0-t were (217.28±98.82) and (222.42±117.98) ng·h·mL-1; AUC0-∞ were (225.91±100.35) and (229.40±119.34) ng·h·mL-1. The main pharmacokinetic parameters of the test and the reference duloxetine hydrochloride in fed test were as follows: Cmax were (20.10±9.56) and (21.30±10.90) ng·mL-1; AUC0-t were (266.99±146.66) and (273.22±168.09) ng·h·mL-1; AUC0-∞ were (277.83±154.73) and (283.51±174.63) ng·h·mL-1. The 90% confidence intervals of the main pharmacokinetic parameters of the test and reference preparations in fasting and fed tests were between 80.00%-125.00%.
Conclusion The test and the reference duloxetine hydrochloride were bioequivalent under fasting and fed conditions.
, authors=Zhen ZHANG
1a, Xiu-jin ZHANG
1b, Ping ZHONG
1b, Wen-ling ZHU
1b, Jian-feng LIU
1b, authorsList=Zhen ZHANG, Xiu-jin ZHANG, Ping ZHONG, Wen-ling ZHU, Jian-feng LIU, authorCompany=null, correspAuthors=Jian-feng LIU, 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=1291404317764866728, articleId=1291404317253161638, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=盐酸度洛西汀肠溶片在中国健康受试者体内的生物等效性研究, 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 评价国产制剂盐酸度洛西汀肠溶片和原研制剂盐酸度洛西汀肠溶胶囊在中国健康受试者体内的生物等效性。
方法 用随机、开放、两周期、两序列、双交叉设计，空腹试验40例、餐后试验48例健康受试者，单剂量口服盐酸度洛西汀受试制剂和参比制剂20 mg。建立高效液相色谱串联质谱法测定血浆中盐酸度洛西汀的浓度，用Phoenix WinNonlin 8.0软件计算药代动力学参数，评价受试制剂和参比制剂的生物等效性。
结果 空腹试验中盐酸度洛西汀受试制剂和参比制剂的主要药代动力学参数：Cmax分别为（16.70±5.94）和（16.70±7.10）ng·mL-1，AUC0-t分别为（217.28±98.82）和（222.42±117.98）ng·h·mL-1，AUC0-∞分别为（225.91±100.35）和（229.40±119.34）ng·h·mL-1。餐后试验中盐酸度洛西汀受试制剂和参比制剂的主要药代动力学参数：Cmax分别为（20.10±9.56）和（21.30±10.90）ng·mL-1，AUC0-t分别为（266.99±146.66）和（273.22±168.09）ng·h·mL-1，AUC0-∞分别为（277.83±154.73）和（283.51±174.63）ng·h·mL-1。空腹和餐后试验中受试制剂和参比制剂主要药代动力学参数的90%置信区间均在80.00%~125.00%。
结论 盐酸度洛西汀受试制剂和参比制剂在空腹和餐后条件下均具有生物等效性。
, authors=张真
1a, 章秀锦
1b, 钟平
1b, 朱文玲
1b, 刘剑锋
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张真（1986-），女，副主任药师，主要从事临床药理学的相关研究
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