[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of perindopril and amlodipine tablets (III) in Chinese healthy subjects under fasting and fed conditions
主要研究目的:按有关生物等效性试验的规定,选择Les Laboratoires Servier为持证商的培哚普利氨氯地平片(III)(商品名:开素达(Coveram),规格:10mg/5mg)为参比制剂,对四川国为制药有限公司生产并提供的受试制剂培哚普利氨氯地平片(III)(规格:10mg/5mg)进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评估两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康志愿受试者口服受试制剂培哚普利氨氯地平片(III)(规格:10mg/5mg)和参比制剂培哚普利氨氯地平片(III)(商品名:开素达(Coveram),规格:10mg/5mg)的安全性。
[Translation] 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.