[Translation] A randomized, open-label, three-period, three-sequence, partially repeated crossover bioequivalence study of telmisartan tablets in healthy volunteers under fasting/fed conditions
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: This study used Telmisartan Tablets (Specification: 40 mg) certified by Tianjin Huajin Pharmaceutical Co., Ltd. as the test preparation and Telmisartan Tablets (trade name: Micardis, Specification: 40 mg) certified by Boehringer Ingelheim International GmbH as the reference preparation to conduct a human bioequivalence test under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.