[Translation] To evaluate the effects of the test formulation Telmisartan Amlodipine Tablets and the reference formulation Telmisartan Amlodipine Tablets Twynsta® on healthy adult subjects in the fasting/postprandial state in a single center, randomized, open-label, single-dose, Two-preparation, two-sequence, four-cycle, double-crossover bioequivalence study
主要目的:考察在空腹及餐后条件下,在中国健康受试者中评价北京天衡药物研究院南阳天衡制药厂研制的替米沙坦氨氯地平片(规格:80mg/5mg)与Boehringer Ingelheim International GmbH持证的替米沙坦氨氯地平片(规格:80mg/5mg,商品名:Twynsta®)的人体生物等效性。
次要目的:评价替米沙坦氨氯地平片受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: To evaluate the effectiveness of Telmisartan and Amlodipine Tablets (specification: 80mg/5mg) developed by Nanyang Tianheng Pharmaceutical Factory of Beijing Tianheng Pharmaceutical Research Institute and Boehringer in Chinese healthy subjects under fasting and postprandial conditions. Ingelheim International GmbH has certified the human bioequivalence of Telmisartan and Amlodipine Tablets (Strength: 80mg/5mg, Trade name: Twynsta®).
Secondary purpose: To evaluate the safety of the test preparation and reference preparation of Telmisartan and Amlodipine Tablets in healthy subjects.