[Translation] A single-center, randomized, open-label, single-dose, two-formulation, four-period, two-sequence, completely repeated crossover bioequivalence study of telmisartan and amlodipine tablets in healthy participants under fasting and fed conditions
主要研究目的:以江苏亚邦爱普森药业有限公司研制的替米沙坦氨氯地平片(规格:40 mg/5 mg)为受试制剂,按生物等效性研究的有关规定,与Boehringer Ingelheim International GmbH持证的替米沙坦氨氯地平片(参比制剂,商品名:Twynsta®,规格:40 mg/5 mg)对比在健康人体内的相对生物利用度,考察两制剂的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在健康参与者中的安全性。
[Translation] Main research purpose: Using Telmisartan Amlodipine Tablets (Specification: 40 mg/5 mg) developed by Jiangsu Yabang Epson Pharmaceutical Co., Ltd. as the test preparation, according to the relevant provisions of bioequivalence studies, the relative bioavailability in healthy humans was compared with Telmisartan Amlodipine Tablets (reference preparation, trade name: Twynsta®, specification: 40 mg/5 mg) certified by Boehringer Ingelheim International GmbH, and the human bioequivalence of the two preparations was investigated.
Secondary research purpose: To observe the safety of the test preparation and the reference preparation in healthy participants.