[Translation] A randomized, open-label, two-dose, single-dose, three-cycle postprandial, three-sequence partial repeat crossover and four-cycle fasting, two-sequence complete repeat crossover bioequivalence study of telmisartan tablets in Chinese healthy subjects
主要目的:以河北山姆士药业有限公司提供的替米沙坦片为受试制剂,按生物等效性研究的有关规定,与Boehringer Ingelheim Hellas Single Member S.A.(持证商:Boehringer Ingelheim International GmbH)公司生产的替米沙坦片(商品名:Micardis®,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。 次要目的:观察受试制剂替米沙坦片和参比制剂替米沙坦片(Micardis® )在健康受试者中的安全性
[Translation] Primary objective: To compare the absorption rate and extent of the Telmisartan Tablets (trade name: Micardis®, reference preparation) produced by Boehringer Ingelheim Hellas Single Member S.A. (license holder: Boehringer Ingelheim International GmbH) with the Telmisartan Tablets provided by Hebei Sams Pharmaceutical Co., Ltd. as the test preparation in healthy subjects according to the relevant provisions of bioequivalence studies, and to investigate the bioequivalence of the two preparations in humans. Secondary objective: To observe the safety of the test preparation Telmisartan Tablets and the reference preparation Telmisartan Tablets (Micardis®) in healthy subjects