[Translation] A single-center, randomized, open-label, single-dose, fasting and postprandial, two-dose, three-sequence, three-period, partially repeated crossover bioequivalence study of telmisartan and amlodipine tablets in healthy Chinese adult subjects
主要研究目的:
考察单次口服(空腹/餐后)受试制剂替米沙坦氨氯地平片(规格:80 mg/5 mg,成都奥邦药业有限公司生产)与参比制剂替米沙坦氨氯地平片(Twynsta®,规格:80 mg/5 mg,持证商为Boehringer Ingelheim International GmbH)在中国成年健康受试者体内的药代动力学特征,分别评价空腹与餐后状态下口服两种制剂的生物等效性,为该药的申报及临床用药提供参考依据。
次要研究目的:
评价受试制剂和参比制剂单次口服(空腹/餐后)在中国成年健康受试者中的安全性。
[Translation] Main study objectives:
To investigate the pharmacokinetic characteristics of the test preparation Telmisartan Amlodipine Tablets (Specifications: 80 mg/5 mg, produced by Chengdu Aobang Pharmaceutical Co., Ltd.) and the reference preparation Telmisartan Amlodipine Tablets (Twynsta®, Specifications: 80 mg/5 mg, licensed by Boehringer Ingelheim International GmbH) in healthy adult Chinese subjects after a single oral administration (fasting/postprandial), and to evaluate the bioequivalence of the two preparations in fasting and postprandial states, respectively, to provide a reference for the application and clinical use of the drug.
Secondary study objectives:
To evaluate the safety of the test preparation and the reference preparation in healthy adult Chinese subjects after a single oral administration (fasting/postprandial).