Study on bioequivalence of irbesartan tablet in healthy volunteers

	Study on bioequivalence of irbesartan tablet in healthy volunteers
	Cheng ChunYan 3; Li Zhen 3; Zhang YiFan1 ; Li SongHua 2
刊名	Pharmaceutical Care and Research
	2012
卷号	12 期号:3 页码:217-220
关键词	irbesartan bioequivalence chromatography,high performance liquid mass spectrometry,tandem
ISSN号	1671-2838
其他题名	厄贝沙坦片的人体生物等效性研究
文献子类	Article
英文摘要	Objective: To study the pharmacokinetics and relative bioavailability of irbesartan tablet in healthy volunteers,and evaluate the bioequivalence between two preparations.Methods:Twenty-four healthy male volunteers were enrolled in the study.A single oral dose(0.15 g) of test and reference tablets were given respectively to the volunteers according to randomized two-way cross-over study design.The washout period was 7 days.The plasma concentration of irbesartan was determined by LC-MS/MS method.Results:The main pharmacokinetic parameters of the test and reference tablets were as follows:cmax(1.890.54) and(1.990.46) mug/ml,tmax(1.630.92) and(1.520.83) h,t1/2(10.96.1) and(11.47.7) h,AUC0-t(9.582.56) and(8.902.87) mug·h·ml-1,AUC0-(10.232.98) and(9.562.93) mug·h·ml-1,respectively.There was no significant difference in main pharmacokinetic parameters between the test and reference tablets(P>0.05).The relative bioavailability of the test irbesartan was(110.521.6)%.Conclusion:The results of statistical analysis show that the two formulations are bioequivalent.
WOS研究方向	General & Internal Medicine ; Pharmacology & Pharmacy (provided by Clarivate Analytics)
语种	中文
CSCD记录号	CSCD:4581124
内容类型	期刊论文
源URL	[http://119.78.100.183/handle/2S10ELR8/267831]
专题	中国科学院上海药物研究所
作者单位	1.Center for Drug Metabolism and Pharmacokinetics Research,Institute of Materia Medica of Shanghai Institute of Biological Sciences,Chinese Academy of Sciences, Shanghai 201203, China.; 2.Department of Cardiovasology,Changhai Hospital,Second Military Medical University, Shanghai 200433, China. 3.Department of Pharmacy,Changhai Hospital,Second Military Medical University, Shanghai 200433, China.;
推荐引用方式 GB/T 7714	Cheng ChunYan,Li Zhen,Zhang YiFan,et al. Study on bioequivalence of irbesartan tablet in healthy volunteers[J]. Pharmaceutical Care and Research,2012,12(3):217-220.
APA	Cheng ChunYan,Li Zhen,Zhang YiFan,&Li SongHua.(2012).Study on bioequivalence of irbesartan tablet in healthy volunteers.Pharmaceutical Care and Research,12(3),217-220.
MLA	Cheng ChunYan,et al."Study on bioequivalence of irbesartan tablet in healthy volunteers".Pharmaceutical Care and Research 12.3(2012):217-220.