Article(id=1291704924350472837, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704811443999077, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.18.014, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1742227200000, receivedDateStr=2025-03-18, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896052682, onlineDateStr=2026-08-05, pubDate=1758988800000, pubDateStr=2025-09-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896052682, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896052681, creator=13701087609, updateTime=1785896052681, updator=13701087609, issue=Issue{id=1291704811443999077, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='18', pageStart='2551', pageEnd='2700', issueExtLink='null', onlineDate='null', pubDate='1758988800000', pubDateStr='2025-09-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896025763, creator='13701087609', updateTime=1785896871490, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291708358743053253, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704811443999077, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291708358743053254, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704811443999077, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2650, endPage=2654, ext={EN=ArticleExt(id=1291704924581159558, articleId=1291704924350472837, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Study on bioequivalence of clindamycin hydrochloride capsules in healthy Chinese volunteers, columnId=1246531407389020354, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Pharmacokinetics and Bioequivalence Study, runingTitle=null, highlight=null, articleAbstract=
Objective To evaluate the bioequivalence of clindamycin hydrochloride capsules test formulation and reference formulation in healthy subjects under fasting and postprandial conditions.
Methods A randomized, open-label, single-dose, two-cycle crossover study was used in this study. A single dose of clindamycin hydrochloride capsules was administered in fasting and postprandial conditions, and the main pharmacokinetic parameters of clindamycin were determined by liquid chromatography tandem mass spectrometry to evaluate the bioequivalence of the two preparations.
Results Twenty- four healthy subjects were involved 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 (2 174.17±616.64) and (2 288.75±678.73) ng·mL-1, AUC0-t were (8 080.29±3 707.51) and (8 496.10±4 801.26) h·ng·mL-1, AUC0-∞ were (8 333.89±3 838.97) and (8 790.21±4 987.28) h·ng·mL-1. The ratio of geometric mean and its 90% confidence interval were 95.27% (89.93%-100.93%), 97.75% (90.39%-105.70%), and 97.51% (90.13%-105.50%). The main PK parameters of the test formulation and reference formulation in the fed group: Cmax were (1 860.00±349.00) and (2 069.04±504.25) ng·mL-1, AUC0-t were (7 829.93±1431.81) and (8 317.23±2 267.65) h·ng·mL-1, AUC0-∞ were (8 053.74±1 486.71) and (8 543.98±2 328.35) h·ng·mL-1. The ratio of geometric mean and its 90% confidence interval were 91.56% (82.23%-101.95%), 96.41% (88.27%～105.31%), and 96.47% (88.14%～105.58%). The 90% confidence intervals of the geometric mean ratios of the main PK parameters of the test preparation and reference preparation for clindamycin hydrochloride capsules in the fasting group and fed group were all within 80.00% to 125.00%. The incidence of adverse events for the test and reference preparations in the fasting group were 25.00% and 20.80%, respectively, while in the postprandial group, they were 25.00% and 33.30%, respectively.
Conclusion In the fasting and postprandial states, clindamycin hydrochloride capsules are bioequivalent to the original reference preparation.
, authors=Rong GAO, Ya-zhong MA, Wei-hong ZHANG, Hai-long YUAN, authorsList=Rong GAO, Ya-zhong MA, Wei-hong ZHANG, Hai-long YUAN, authorCompany=null, correspAuthors=Hai-long YUAN, 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=1291704924933481095, articleId=1291704924350472837, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=盐酸克林霉素胶囊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 在空腹和餐后条件下，评价盐酸克林霉素胶囊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 用随机、开放、两周期交叉、单次给药试验设计，分别在空腹和餐后条件下单次服用盐酸克林霉素胶囊受试或参比制剂，利用液相色谱串联质谱测定克林霉素的主要药代动力学参数评价两制剂的生物等效性。
结果 空腹组和餐后组分别入组24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（2 174.17±616.64）和（2 288.75±678.73）ng·mL-1，AUC0-t分别为（8 080.29±3 707.51）和（8 496.10±4 801.26）h·ng·mL-1，AUC0-∞分别为（8 333.89±3 838.97）和（8 790.21±4 987.28）h·ng·mL-1；Cmax、AUC0-t和AUC0-∞几何均数的比值及其90%置信区间分别为95.27%（89.93%～100.93%）、97.75%（90.39%～105.70%）和97.51%（90.13%～105.50%）。餐后组受试制剂与参比制剂的主要PK参数：Cmax分别为（1 860.00±349.00）和（2 069.04±504.25）ng·mL-1，AUC0-t分别为（7 829.93±1 431.81）和（8 317.23±2 267.65）h·ng·mL-1，AUC0-∞分别为（8 053.74±1 486.71）和（8 543.98±2 328.35）h·ng·mL-1；Cmax、AUC0-t和AUC0-∞几何均数的比值及其90%置信区间分别为91.56%（82.23%～101.95%）、96.41%（88.27%～105.31%）和96.47%（88.14%～105.58%）。空腹组和餐后组盐酸克林霉素胶囊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%。空腹组受试制剂和参比制剂的不良事件发生率分别为25.00%和20.80%，餐后组分别为25.00%和33.30%。
结论 在空腹和餐后状态下，受试制剂的盐酸克林霉素胶囊与原研参比制剂生物等效。
, authors=高茸, 马亚中, 张伟红, 袁海龙, authorsList=高茸, 马亚中, 张伟红, 袁海龙, authorCompany=null, correspAuthors=袁海龙, authorNote=
高茸（1988-），女，主管药师，主要从事药物临床试验相关工作
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