Title: Parmacokinetics and bioequivalence of compound valsartan tablets in healthy volunteers
Abstract: Objective To study the pharmacokinetics and bioequivalence of compound valsartan tablets in Chinese healthy volunteers. Methods Twenty healthy male voluteers were divided into 2 groups. The serum samples collected after a sigle oral at the dose of 160 mg valsartan and 25 mg hydrochlorothiazide were determined by RP-HPLC-fluorescence. The pharmacokinetic parameters were calculated by BAPP 2.0 software. Results The main pharmacokinetic parameters of the tablets (test) and the capsules (reference) were as following: valsartan :t_ max (3.1±0.7)and (3.0±0.7)h,C_ max were (4932.82±1557.19) and (4975.94±1472.51)μg·L -1 , AUC_ 0-t were (30.54±10.73),(29.54±10.68)mg·h·L -1 ;hydrochlorothiazide:t_ max were (2.2±0.9) and (2.2±0.6)h , C_ max were( 196.04±13.95) and (185.77±16.350) μg·L -1 ,AUC_ 0-t were (1.29±0.23) and (1.34±0.28)mg·h·L -1 . Conclusion The results of statistics analysis shown that the tablets and the capsules were bioequivalent.
Publication Year: 2006
Publication Date: 2006-01-01
Language: en
Type: article
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