Anhui Jiahe Pharmaceutical Co., Ltd.

Main purpose: To investigate the relative bioavailability of the test preparation amlodipine atorvastatin calcium tablets (specifications: 5 mg/20 mg (in terms of amlodipine/atorvastatin), produced by Anhui Jiahe Pharmaceutical Co., Ltd.) and the reference preparation amlodipine atorvastatin calcium tablets (DaDaYi®, specifications: 5 mg/20 mg (in terms of amlodipine/atorvastatin), produced by Pfizer Manufacturing Deutschland GmbH) in healthy Chinese adults after a single oral administration on an empty stomach/after a meal, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations. Secondary purpose: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese adults after a single oral administration on an empty stomach/after a meal.

To investigate the relative bioavailability of the test preparation perindopril amlodipine tablets (III) (specification: each tablet contains 10 mg perindopril arginine and 5 mg amlodipine besylate (calculated as amlodipine), produced by Anhui Jiahe Pharmaceutical Co., Ltd.) and the reference preparation perindopril amlodipine tablets (III) (trade name: Coveram®, specification: each tablet contains 10 mg perindopril arginine and 5 mg amlodipine besylate (calculated as amlodipine), produced by Servier (Ireland) Industries Ltd) in healthy Chinese adults after a single oral administration on an empty stomach/after a meal, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations. Secondary study objectives: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese adults after a single oral administration on an empty stomach/after a meal.

Healthy Chinese subjects were used as the test subjects. A self-crossover design was used to determine the time course of acipimox in plasma after administration of acipimox capsules developed by Anhui Jiahe Pharmaceutical Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Acipimox capsules (trade name: Olbetam®, specification: 0.25g) certified by Pfizer Limited and produced by Pharmacia Italia SpA were used as reference to evaluate the bioequivalence between the preparations and to observe the safety of acipimox capsules in healthy Chinese subjects.