[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the test preparation Perindopril Amlodipine Tablets (III) (Specifications: 10 mg: 5 mg) and the reference preparation Kaisuda® (Specifications: 10 mg: 5 mg) in healthy adult subjects in the fasting and fed state.
主要研究目的:研究空腹和餐后状态下单次口服受试制剂培哚普利氨氯地平片(Ⅲ)(规格:10 mg:5 mg,浙江北生药业汉生制药有限公司生产)与参比制剂培哚普利氨氯地平片(Ⅲ)(开素达®,规格:10 mg:5 mg,Servier (Ireland) Industries Ltd.生产)在健康受试者体内的药代动力学特征,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的:研究受试制剂培哚普利氨氯地平片(Ⅲ)(规格:10 mg:5 mg)和参比制剂开素达®(规格:10 mg:5 mg)在健康受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation Perindopril Amlodipine Tablets (III) (Specifications: 10 mg: 5 mg, produced by Zhejiang Beisheng Pharmaceutical Hansheng Pharmaceutical Co., Ltd.) and the reference preparation Perindopril Amlodipine Tablets (III) (Kesoda®, Specifications: 10 mg: 5 mg, produced by Servier (Ireland) Industries Ltd.) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary purpose of the study: to study the safety of the test preparation Perindopril Amlodipine Tablets (III) (Specifications: 10 mg: 5 mg) and the reference preparation Kaisoda® (Specifications: 10 mg: 5 mg) in healthy subjects.