Article(id=1322627811295215966, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627786464936095, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1590076800000, acceptedDateStr=2020-05-22, onlineDate=1793268643449, onlineDateStr=2026-10-29, pubDate=1615737600000, pubDateStr=2021-03-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793268643449, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793268643449, creator=13701087609, updateTime=1793268643449, updator=13701087609, issue=Issue{id=1322627786464936095, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='5', pageStart='385', pageEnd='480', issueExtLink='null', onlineDate='null', pubDate='1615737600000', pubDateStr='2021-03-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793268637529, creator='13701087609', updateTime=1793269201588, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322630152530539005, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627786464936095, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322630152530539006, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627786464936095, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=411, endPage=416, ext={EN=ArticleExt(id=1322627811446210911, articleId=1322627811295215966, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Bioequivalence of metformin hydrochloride sustained release tablets in healthy human conditions, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To study the pharmacokinetic characteristics of metformin hydrochloride sustained-release tablets (0.5 g/tablet) in healthy volunteers, and to evaluate the bioequivalence of the two preparations.
Methods: A randomized, open, double-period, double-crossover trial was conducted. The tested reagent and reference reagent (Glucophage® XR®) for oral metformin hydrochloride sustained release tablets were applied to 36 healthy subjects in fasting/fed state. In this clinical trial, the validated HPLC/tandem mass spectrometry method was used to determine the concentration of metformin in human plasma of 14 time intervals in 48 h. The pharmacokinetic parameters were calculated.
Results: After the volunteers were given tested and reference preparations in fasting/fed state, bioequivalence was evaluated by Cmax of metformin. The geometric mean ratio of Cmax was 101.12%, the 90%CI was 94.68%~108.00%, and the intra-individual variation was 16.36%. The geometric mean ratio of AUC0-t was 100.18%, the 90%CI was 95.13%~105.51%, and the intra-individual variation was 12.85%. The geometric mean ratio of AUC0-∞ was 101.06%, 90%CI was 95.86%~106.54%, and intra-individual variation was 13.11%. The geometric mean ratio of Cmax was 94.45%, the 90%CI was 90.13%~98.97%, and the intra-individual variation was 11.39%. When the AUC of metformin was used to evaluate the bioequivalence of the tested and reference preparations, the geometric mean ratio of AUC0-t was 103.21%, the 90%CI was 100.27%~106.24%, and the intra-individual variation was 7.04%. The geometric mean ratio of AUC0-∞ was 103.24%, 90%CI was 100.31%~106.26%, and intra-individual variation was 7.01%.
Conclusion: Both preparations were bioequivalent in fasting/postprandial status. The liquid chromatography-tandem mass spectrometry (LC-MS/MS) used in this study was accurate, rapid, sensitive and precise, providing theoretical reference for clinical safe drug use.
, authors=Guang-wen LIU
1, Jia-hui CHEN
1, Zhen-yue GAO
2, Meng-fan ZHANG
2, Hao LI
3, Hai-miao YANG
1, authorsList=Guang-wen LIU, Jia-hui CHEN, Zhen-yue GAO, Meng-fan ZHANG, Hao LI, Hai-miao YANG, authorCompany=null, correspAuthors=Hai-miao YANG, 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=1322627811815309664, articleId=1322627811295215966, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=盐酸二甲双胍缓释片健康人体生物等效性评价, columnId=1236331162205999476, journalTitle=中国新药杂志, columnName=临床研究, runingTitle=null, highlight=null, articleAbstract=
目的： 研究盐酸二甲双胍缓释片0.5 g·片-1在健康人体的药动学特征，并对2种制剂的生物等效性进行评价。
方法： 空腹/餐后各36名健康受试者口服盐酸二甲双胍缓释片受试制剂和参比制剂（Glucophage® XR®），采用随机、开放、两周期、两交叉空腹/餐后状态下生物等效性试验。研究采用已验证的液相色谱-串联质谱法作为测定人血浆中二甲双胍浓度的分析方法，测定服药后48 h共14个时间点的血药浓度，计算药动学参数。
结果： 受试者空腹状态下口服受试制剂和参比制剂后，以二甲双胍的Cmax评价受试制剂与参比制剂的生物等效性，Cmax的几何均值比值为101.12%，90%CI为94.68%~108.00%，个体内变异为16.36%。AUC0-t的几何均值比值为100.18%，90%CI为95.13%~105.51%，个体内变异为12.85%；AUC0-∞的几何均值比值为101.06%，90%CI为95.86%~106.54%，个体内变异为13.11%。受试者餐后状态下口服受试制剂和参比制剂后，Cmax的几何均值比值为94.45%，90%CI为90.13%~98.97%，个体内变异为11.39%；以二甲双胍的AUC评价受试制剂与参比制剂的生物等效性，AUC0-t的几何均值比值为103.21%，90%CI为100.27%~106.24%，个体内变异为7.04%；AUC0-∞的几何均值比值为103.24%，90%CI为100.31%~106.26%，个体内变异为7.01%。
结论： 2种制剂在空腹/餐后状态下均具有生物等效性，液相色谱-串联质谱（LC-MS/MS）法准确快速，为临床安全用药提供理论参考。
, authors=刘广文
1, 陈佳惠
1, 高振月
2, 张梦凡
2, 李浩
3, 杨海淼
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, correspAuthorsNote=
杨海淼，女，主任医师，主要从事中药、天然药以及化药为方向的药动学研究和临床试验管理的研究。联系电话：（0431）86177635，E-mail：
yhm7876@126.com。
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刘广文，男，主治医师，主要从事药物临床试验及管理工作的研究。联系电话：（0431）86177635，E-mail：liuguangwen1109@126.com。
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