Shanghai Yishengyuan Pharmaceutical Co., Ltd.

Dopamine capsules (specification: 200 mg/50 mg) produced by Shanghai Yishengyuan Pharmaceutical Co., Ltd. were used as the test preparation, and dopamine capsules (trade name: Madopar, specification 200 mg/50 mg) produced by Roche Products Ltd (UK) were used as the reference preparation. The pharmacokinetic parameters of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent.

The pharmacokinetic (PK) behavior of adefovir in healthy Chinese subjects was studied after a single oral administration of the test formulation of adefovir dipivoxil tablets (Uhedin®, 10 mg/tablet, Shanghai Yishengyuan Pharmaceutical Co., Ltd.) and the reference formulation of adefovir dipivoxil tablets (Hepsera®, 10 mg/tablet, Gilead Science Inc) on an empty stomach and after a meal, and the bioequivalence of the two formulations after an empty stomach and after a meal was evaluated. Secondary objective: To evaluate the safety of the test formulation and the reference formulation of adefovir dipivoxil tablets in healthy Chinese subjects after a single oral administration.

The test preparation was doubasil capsules (specification: 200 mg/50 mg) produced by Shanghai Yishengyuan Pharmaceutical Co., Ltd., and the reference preparation was doubasil capsules (trade name: Madopar, specification 200 mg/50 mg) produced by Roche Products Ltd (UK). The pharmacokinetic parameters of levodopa and benserazide of the two preparations under fasting state were investigated, and the rationality of the blood drug concentration analysis method and the settings of blood sampling time, sampling volume, time interval, etc. were verified. The coefficient of variation was estimated, and the bioequivalence of the two preparations was preliminarily evaluated.