[Translation] A single-center, randomized, open-label, single-dose, two-drug, two-sequence, four-period, double-crossover bioequivalence study to evaluate the bioequivalence of the test preparation, Telmisartan Amlodipine Tablets, and the reference preparation, Telmisartan Amlodipine Tablets Twynsta®, in healthy adult subjects under fasting/fed conditions
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] Primary objective: To investigate the bioequivalence of Telmisartan Amlodipine Tablets (Specification: 80mg/5mg) developed by Beijing Tianheng Pharmaceutical Research Institute Nanyang Tianheng Pharmaceutical Factory and Telmisartan Amlodipine Tablets (Specification: 80mg/5mg, Trade Name: Twynsta®) certified by Boehringer Ingelheim International GmbH in healthy Chinese subjects under fasting and postprandial conditions.
Secondary objective: To evaluate the safety of the test and reference preparations of Telmisartan Amlodipine Tablets in healthy subjects.