[Translation] A single-center, randomized, open-label, two-dose, single-dose, three-period, three-sequence, partially repeated crossover fasting/fed bioequivalence study of telmisartan and amlodipine tablets in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂替米沙坦氨氯地平片(持证商:沈阳达善医药科技有限公司)与参比制剂替米沙坦氨氯地平片(持证商:Boehringer Ingelheim International GmbH,商品名:Twynsta®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:观察受试制剂替米沙坦氨氯地平片和参比制剂替米沙坦氨氯地平片在健康受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the oral administration of the test preparation Telmisartan Amlodipine Tablets (licensee: Shenyang Dashan Pharmaceutical Technology Co., Ltd.) and The pharmacokinetic behavior of the reference preparation Telmisartan and Amlodipine Tablets (licensee: Boehringer Ingelheim International GmbH, trade name: Twynsta®) in healthy subjects was evaluated to evaluate the bioequivalence of the two preparations. .
Secondary purpose: To observe the safety of the test preparation Telmisartan Amlodipine Tablets and the reference preparation Telmisartan Amlodipine Tablets in healthy subjects.