[Translation] A single-center, randomized, open-label, fasting and fed, single-dose, two-dose, three-sequence, three-period crossover bioequivalence study of telmisartan and amlodipine tablets in healthy Chinese adult subjects
主要研究目的:
考察单次口服(空腹/餐后)受试制剂替米沙坦氨氯地平片(规格:80mg/5mg,海南赛立克药业有限公司生产,海南赛立克药业有限公司提供)与参比制剂替米沙坦氨氯地平片(Twynsta®,规格:80mg/5mg,Boehringer Ingelheim International GmbH持证,海南赛立克药业有限公司提供)在中国成年健康受试者体内的药代动力学特征,评价空腹与餐后状态下口服两种制剂的生物等效性。
次要研究目的:
评价受试制剂和参比制剂单次口服(空腹/餐后)在中国成年健康受试者中的安全性。
[Translation] Main study objectives:
To investigate the pharmacokinetic characteristics of the test preparation Telmisartan Amlodipine Tablets (Specifications: 80mg/5mg, produced by Hainan Selike Pharmaceutical Co., Ltd., provided by Hainan Selike Pharmaceutical Co., Ltd.) and the reference preparation Telmisartan Amlodipine Tablets (Twynsta®, Specifications: 80mg/5mg, certified by Boehringer Ingelheim International GmbH, provided by Hainan Selike Pharmaceutical Co., Ltd.) in healthy adult Chinese subjects, and to evaluate the bioequivalence of the two preparations in fasting and fed states.
Secondary study objectives:
To evaluate the safety of the test preparation and the reference preparation in healthy adult Chinese subjects after a single oral administration (fasting/fed).