Article(id=1291704816393285669, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704786705993936, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.20.012, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1750780800000, receivedDateStr=2025-06-25, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896026942, onlineDateStr=2026-08-05, pubDate=1761580800000, pubDateStr=2025-10-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896026942, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896026942, creator=13701087609, updateTime=1785896026942, updator=13701087609, issue=Issue{id=1291704786705993936, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='20', pageStart='2851', pageEnd='3000', issueExtLink='null', onlineDate='null', pubDate='1761580800000', pubDateStr='2025-10-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896019864, creator='13701087609', updateTime=1785896741492, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291707813508702571, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704786705993936, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291707813508702572, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704786705993936, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2918, endPage=2923, ext={EN=ArticleExt(id=1291704816619778086, articleId=1291704816393285669, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Bioequivalence trial of torasemide 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 investigate the bioequivalence of oral torasemide tablets in healthy subjects under fasting and postprandial states.
Methods A single-center, randomized, open-label, single-dose, double-period, double-cross study design was adopted. Each period involved a single oral administration of 10 mg of torasemide under fasting or postprandial conditions. The plasma drug concentration of torasemide was determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The pharmacokinetic data were calculated and bioequivalence evaluation was performed.
Results The pharmacokinetic parameters of the test formulation and reference formulation in the fasting group were as follows: Cmax were (1 664.91±353.89) and (1 645.29±363.80) ng·mL-1, AUC0-t were (3 459.38±659.07) and (3 468.21±616.06) h·ng·mL-1, AUC0-∞ were (3 637.12±700.25) and (3 644.48±651.24) h·ng·mL-1. The pharmacokinetic parameters of the test formulation and reference formulation in the postprandial group were as follows: Cmax were (1 018.18±336.79) and (883.97±172.43) ng·mL-1, AUC0-t were (3 974.56±963.76) and (3 924.70±943.83) h·ng·mL-1, AUC0-∞ were (4 192.17±1081.81) and (4 143.90±1068.71) h·ng·mL-1; the 90% confidence intervals of the ratios of the pharmacokinetic parameters of the test formulation and reference formulation (test formulation/reference formulation) under fasting and postprandial conditions were all within the statistically equivalent range.
Conclusion Torasemide tablets test formulation and the reference formulation have bioequivalence under both fasting and postprandial administration conditions.
, authors=Cheng-long YU
1, Hong-min ZHOU
2, Min XIAO
2, Yan MA
2, Jia JI
2, Yuan YUAN
2, Shuang LI
2, Wen-hua XUE
3, authorsList=Cheng-long YU, Hong-min ZHOU, Min XIAO, Yan MA, Jia JI, Yuan YUAN, Shuang LI, Wen-hua XUE, authorCompany=null, correspAuthors=Wen-hua XUE, 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=1291704817592856615, articleId=1291704816393285669, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=托拉塞米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 研究空腹及餐后状态下口服托拉塞米片在中国健康受试者体内的生物等效性。
方法 用单中心、随机、开放、单剂量、双周期、双交叉的研究设计。空腹组和餐后组各入组34例受试者，每周期空腹或餐后条件下单次口服托拉塞米10 mg。采用液相色谱串联质谱（LC-MS/MS）法测定血浆中托拉塞米的血药浓度，计算药代动力学动学参数并进行生物等效性评价。
结果 空腹组口服受试试剂和参比试剂的药动学参数如下：Cmax为（1 664.91±353.89）和（1 645.29±363.80）ng·mL-1，AUC0-t为（3 459.38±659.07）和（3 468.21±616.06）h·ng·mL-1，AUC0-∞为（3 637.12±700.25）和（3 644.48±651.24）h·ng·mL-1；餐后口服受试试剂和参比试剂的药动学参数如下：Cmax为（1 018.18±336.79）和（883.97±172.43）ng·mL-1，AUC0-t为（3 974.56±963.76）和（3 924.70±943.83）h·ng·mL-1，AUC0-∞为（4 192.17±1 081.81）和（4 143.90±1 068.71）h·ng·mL-1；空腹和餐后条件下，受试试剂和参比试剂的药物代谢动力学参数的比值（受试制剂/参比制剂）的90%置信区间均位于统计学中的等效范围。
结论 托拉塞米片受试制剂与参比制剂在空腹及餐后状态下均具有生物等效性。
, authors=于成龙
1, 周红敏
2, 肖敏
2, 马龑
2, 纪佳
2, 袁媛
2, 李爽
2, 薛文华
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