Article(id=1236342825625908106, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236342820131361209, 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=1657468800000, acceptedDateStr=2022-07-11, onlineDate=1772696699767, onlineDateStr=2026-03-05, pubDate=1677513600000, pubDateStr=2023-02-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772696699767, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772696699767, creator=13701087609, updateTime=1772696699767, updator=13701087609, issue=Issue{id=1236342820131361209, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='4', pageStart='329', pageEnd='440', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772696698458, creator=13701087609, updateTime=1772696766437, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236343105318875204, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236342820131361209, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236343105318875205, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236342820131361209, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=435, endPage=440, ext={EN=ArticleExt(id=1236342825906926481, articleId=1236342825625908106, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Bioequivalence of two formulations of low-dose metformin hydrochloride tablets under postprandial condition, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To study the pharmacokinetics of metformin hydrochloride tablets (manufactured by Beijing Zhongxin Pharmaceutical Co., Ltd.) and the reference preparation metformin hydrochloride tablets (trade name: Glycoran®, manufactured by Nippon Shinyaku Co., Ltd., Japan) in healthy subjects after single-dose administration under postprandial state, evaluate their bioequivalence, and observe the safety.
Methods: Thirty-six healthy subjects were randomly divided into two groups, 18 in each group. After having high-fat meal, the subjects took the test or reference preparations. Blood samples were collected at 0 h (after meal and before administration) and at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12 and 24 h after administration. Plasma levels of metformin were measured. The trial consisted of two periods of cross administration and 7-day washout period. PhoenixTM WinNonlin® 8.1 software was used to estimate the non-compartmental pharmacokinetic parameters, and SAS9.4 software was used for statistical description and bioequivalence analysis. If the 90% confidence interval of geometric mean ratio of main pharmacokinetic parameters (Cmax, AUC0-T, AUC0-∞) of T/R were within 80.00%~125.00% equivalent interval, it was safely proved that the two preparations were bioequivalent.
Results: One out of 36 subjects dropped-out due to adverse events. The main pharmacokinetic parameters of the test and reference preparations were as follows: Cmax were (418.42±94.72) and (399.52±79.49) ng·mL-1, AUC0-t were (3 402.04±803.32) and (3 219.06±704.13) ng·h·mL-1; AUC0-∞ (3 458.50±815.42) and (3 276.11±715.12) ng·h·mL-1. The geometric mean ratios of Cmax, AUC0-t, AUC0-∝, and their 90% confidence intervals were 103.11% (98.69%~107.72%), 104.73 (100.11%~109.57%), and 104.63% (100.03%~109.44%), respectively. All were within the bioequivalent range of 80.00%~125.00%. No serious adverse events and unexpected adverse events occurred during the trial.
Conclusion: The test preparation is bioequivalent to the reference preparation after a single-dose oral administration under postprandial condition in healthy Chinese subjects. The two preparations have good safety and tolerability.
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目的： 研究餐后状态下单次口服受试制剂盐酸二甲双胍片与参比制剂盐酸二甲双胍片在健康受试者体内的药动学及其生物等效性。观察2种制剂在健康受试者中的安全性。
方法： 入选36例健康受试者，随机分成2组，每组各18例，进食高脂餐后单次口服受试制剂或参比制剂，于给药0 h（进餐结束后、给药前）和给药后1，2，2.5，3，3.5，4，4.5，5，5.5，6，7，8，10，12和24 h采集血样，检测血浆二甲双胍浓度。本项试验为两周期、交叉给药，清洗期为7 d。采用PhoenixTM WinNonlin® 8.1软件进行非房室模型药动学参数估算，采用SAS9.4软件进行统计描述与生物等效性评价分析。如果受试制剂与参比制剂的主要药动学参数（Cmax，AUC0~t，AUC0~∞）几何均值比的90%置信区间均在80.00%~125.00%等效区间内，则证明两制剂生物等效。
结果： 36例受试者中有1例因不良事件脱落。受试制剂与参比制剂的主要药动学参数：Cmax分别为（418.42±94.72）和（399.52±79.49） ng·mL-1，AUC0~t分别为（3 402.04±803.32）和（3 219.06±704.13） ng·h·mL-1；AUC0~∞分别为（3 458.50±815.42）和（3 276.11±715.12） ng·h·mL-1；二者Cmax和AUC0~t，AUC0~∝几何均值比及其90%置信区间分别为103.11%（98.69%~107.72%），104.73%（100.11%~109.57%）和104.63%（100.03%~109.44%），均在80.00%~125.00%的生物等效区间内。试验过程中未发生严重不良事件和非预期不良事件。
结论： 受试制剂与参比制剂在中国健康受试者餐后单次口服给药条件下具有生物等效性，2种制剂安全性和耐受性好。
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王兴河，男，博士生导师，教授，主任医师，主要从事抗肿瘤药物研发及新药各期临床试验研究。联系电话：(010)63926401，E-mail:
wangxh@bjsjth.cn。
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, authorsList=孙明利, 许馨文, 魏雅丽, 白海红, 刘龙, 佟媛旭, 王瑜, 刘晨, 张薇, 刘慧娟, 李璞, 李银娟, 刘菊, 雷春璞, 王兴河)}, authors=[Author(id=1236342826586403762, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236342825625908106, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=sunmingli@bjsjth.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236342826695455668, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236342825625908106, authorId=1236342826586403762, language=EN, stringName=Ming-li SUN, firstName=Ming-li, middleName=null, lastName=SUN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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1首都医科大学附属北京世纪坛医院药物Ⅰ期临床试验研究室，北京 100038, bio={"content":"
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孙明利，男，博士，副主任医师，主要从事心血管病诊疗和药物Ⅰ期临床试验研究。联系电话：(010)63926882，E-mail: sunmingli@bjsjth.cn。
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