Amlodipine/Perindopril Arginine

Main study purpose: According to the relevant provisions of bioequivalence test, perindopril amlodipine tablets (III) (trade name: Coveram, specification: 10mg/5mg) with Les Laboratoires Servier as the licensee was selected as the reference preparation, and the test preparation perindopril amlodipine tablets (III) (specification: 10mg/5mg) produced and provided by Sichuan Guowei Pharmaceutical Co., Ltd. was subjected to fasting and postprandial human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary study purpose: To observe the safety of oral administration of the test preparation perindopril amlodipine tablets (III) (specification: 10mg/5mg) and the reference preparation perindopril amlodipine tablets (III) (trade name: Coveram, specification: 10mg/5mg) in healthy volunteers.

Perindopril Amlodipine Tablets (III) (Specification: 10 mg/5 mg) produced by Jiangsu Jiayi Pharmaceutical Co., Ltd. was used as the test preparation, and Perindopril Amlodipine Tablets (III) (Kaisuda®, Specification: 10 mg/5 mg) produced by LES LABORATOIRES SERVIER was used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after a single dose in the fed state were investigated to evaluate whether the two preparations were bioequivalent; at the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.