In Vitro Dissolution and In Vivo Bioequivalence Evaluation of Two Metformin Extended-Release Tablets

doi:10.1002/cpdd.857

科研成果详情

题名	In Vitro Dissolution and In Vivo Bioequivalence Evaluation of Two Metformin Extended-Release Tablets
作者	Zhou, Ziye1; Wang, Chenxiang1; Li, Min 2; Lan, Qin 2; Yu, Chao1; Yu, Guoxin 3; Xia, Yan 4; Chen, Huafang2; Zhang, Xiuhua2
发表日期	2021-04
发表期刊	CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT 影响因子和分区
语种	英语
原始文献类型	Article
关键词	bioequivalence Chinese subjects dissolution metformin safety
其他关键词	FIXED-DOSE COMBINATION ; PHARMACOKINETICS ; FOOD ; MG ; CHINESE
摘要	The objective of the present study was to evaluate the bioequivalence between generic and branded metformin extended-release (ER) tablets in Chinese subjects. We tested bioequivalence in vitro and in vivo using a comparative dissolution study and a comparative pharmacokinetic trial. Safety assessments were conducted throughout the entire trial period. The dissolution profiles of the generic formulation expressed obvious extended-release properties, similar to those of the branded formulation (f(2)> 60.0%). Consistent with the result of the in vitro study, no remarkable differences were found in terms of pharmacokinetic profiles between generic and branded formulations. The 90% confidence intervals of Ln AUC(0-36 h), Ln AUC(0-infinity), and Ln C(max)from generic formulation versus branded formulation were 91.4% to 105.0%, 91.3% to 104.7%, and 101.2% to 119.4%, respectively. During the entire trial period, 4 subjects experienced 11 adverse events. All these were mild and spontaneously resolved. The results obtained from the present study suggest that the generic and branded metformin ER tablets were bioequivalent in Chinese subjects.
资助项目	Haili Pharmaceutical Co., Ltd, Hainan, China
出版者	WILEY
出版地	HOBOKEN
ISSN	2160-7648
EISSN	2160-7648
卷号	10 期号:4 页码:414-419
DOI	10.1002/cpdd.857
页数	6
WOS类目	Pharmacology & Pharmacy
WOS研究方向	Pharmacology & Pharmacy
WOS记录号	WOS:000551608900001
收录类别	SCIE ; PUBMED ; SCOPUS
URL	查看原文
PubMed ID	32706921
SCOPUSEID	2-s2.0-85088367415
通讯作者地址	[Zhang, Xiuhua]Office of Drug Clinical Trial Institution,First Affiliated Hospital of Wenzhou Medical University,Zhejiang,China
Scopus学科分类	Pharmaceutical Science;Pharmacology (medical)
引用统计	被引频次：4[WOS] [WOS记录] [WOS相关记录]
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/18287
专题	附属第一医院_药学部药学部附属第一医院_药物临床试验机构办公室
通讯作者	Zhang, Xiuhua
作者单位	1.Department of Pharmacy,First Affiliated Hospital of Wenzhou Medical University,Zhejiang,China; 2.Office of Drug Clinical Trial Institution,First Affiliated Hospital of Wenzhou Medical University,Zhejiang,China; 3.Haili Pharmaceutical Co.,Ltd,Hainan,China; 4.Leeway Biological Technology Co.,Ltd,Jiangsu,China
第一作者单位	附属第一医院
通讯作者单位	附属第一医院
第一作者的第一单位	附属第一医院
推荐引用方式 GB/T 7714	Zhou, Ziye,Wang, Chenxiang,Li, Min,et al. In Vitro Dissolution and In Vivo Bioequivalence Evaluation of Two Metformin Extended-Release Tablets[J]. CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT,2021,10(4):414-419.
APA	Zhou, Ziye., Wang, Chenxiang., Li, Min., Lan, Qin., Yu, Chao., ... & Zhang, Xiuhua. (2021). In Vitro Dissolution and In Vivo Bioequivalence Evaluation of Two Metformin Extended-Release Tablets. CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 10(4), 414-419.
MLA	Zhou, Ziye,et al."In Vitro Dissolution and In Vivo Bioequivalence Evaluation of Two Metformin Extended-Release Tablets".CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT 10.4(2021):414-419.