2009•The Chinese Journal of Clinical PharmacologyRequires access
Bioequivalence of amlodipine besylate tablets in Chinese healthy volunteers
Yuan Lv, Cui Yi hong, Zisheng Kang, Ming Zhang, Yongsheng Wang, Yan Liu, Tianyun Li, Man Zhang, Yonghong Xiao
Open publisher page 1 citations
Abstract
Objective To study the bioequivalence of two kinds of amlodipine besylate tablets in Chinese healthy volunteers.Methods Twenty four male subjects enrolled the study and took 5 mg test drug(domestic) and reference drug(imported) according to the randomized scheme in the first and second period.LC-MS/MS was used to assay the concentration of amlodipine in plasma.DAS statstic ananlysis software was use to evaluate the bioequivalene of two kinds of amlodipine besylate tablets.Results Main pharmacokiretic parameters of 5 mg test drug and reference drug were as follow: t1/2 were(47.15 ±17.28) and(43.22 ±16.63)h respectively;tmax were(5.81 ±2.09) and(6.38 ±2.33)h respectively;Cmax were(4.77 ±1.28) and(4.37 ±1.14)ng·mL-1respectively;AUC0-t were(176.39 ±57.95)and(182.55 ±58.36)ng·mL-1· h;AUC0-∞ were(185.65 ±59.01)and(192.83 ±62.72)ng·mL-1·h respectively.The mean bioavalibility values of AUC0-t and AUC0-∞ were(98.1±18.5)% and(98.6±20.0)%.Conclusion Two kinds of amlodipine besylate tablets were bioequivalent drug products.