[Translation] A randomized, open-label, three-cycle, three-sequence, partial repeat crossover design bioequivalence trial of Telmisartan tablets in healthy humans in fasting/fed state
主要目的:本研究以天津华津制药有限公司持证的替米沙坦片(规格:40mg)为受试制剂,Boehringer Ingelheim International GmbH持证的替米沙坦片(商品名:Micardis,规格:40mg)为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制剂和参比制剂在健康受试者体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者的安全性。
[Translation] Main purpose: In this study, telmisartan tablets (specification: 40mg) licensed by Tianjin Huajin Pharmaceutical Co., Ltd. were used as the test preparation, and Telmisartan tablets (trade name: Micardis) licensed by Boehringer Ingelheim International GmbH (trade name: Micardis, specifications: 40mg) is the reference preparation, and the human bioequivalence test in fasting/postprandial state is carried out to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects.
Secondary objective: To observe the safety of the test product and the reference product in healthy subjects.