[Translation] A single-center, randomized, open-label, fasting and postprandial single-dose, two-drug, three-sequence, three-cycle partial repeat crossover bioequivalence study of telmisartan and amlodipine tablets in Chinese adult healthy subjects sex studies
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 research purposes:
Investigate the single oral (fasting/after meal) test preparation Telmisartan Amlodipine Tablets (Specification: 80 mg/5 mg, produced by Chengdu Aobang Pharmaceutical Co., Ltd.) and the reference preparation Telmisartan Amlodipine Tablets (Twynsta®, specification: 80 mg/5 mg, licensed by Boehringer Ingelheim International GmbH) in Chinese adult healthy subjects, the pharmacokinetic characteristics of the two formulations were evaluated in the fasting and postprandial state. Bioequivalence provides a reference for the application and clinical application of the drug.
Secondary research purposes:
To evaluate the safety of a single oral administration (fasting/fed) of the test preparation and the reference preparation in Chinese adult healthy subjects.