[Translation] A randomized, open-label, single-dose, two-sequence, two-formulation, four-period, completely repeated crossover bioequivalence study of a single oral dose of benazepril-hydrochlorothiazide tablets in healthy subjects in the fasting and fed state
主要研究目的
研究空腹和餐后状态下单次口服受试制剂贝那普利氢氯噻嗪片(规格:每片含盐酸贝那普利10 mg,氢氯噻嗪12.5 mg,生产单位:深圳信立泰药业股份有限公司)与参比制剂贝那普利氢氯噻嗪片(商品名:Lotensin HCT®,规格:每片含盐酸贝那普利10 mg,氢氯噻嗪12.5 mg,生产单位:Validus Pharmaceuticals LLC)在健康成年受试者体内的药代动力学(PK)特征。
次要研究目的
评价健康受试者单次口服贝那普利氢氯噻嗪片受试制剂和参比制剂后的安全性。
[Translation] Main study objectives
To study the pharmacokinetic (PK) characteristics of the test preparation benazepril hydrochlorothiazide tablets (specification: each tablet contains 10 mg benazepril hydrochloride and 12.5 mg hydrochlorothiazide, produced by Shenzhen Xinlitai Pharmaceutical Co., Ltd.) and the reference preparation benazepril hydrochlorothiazide tablets (trade name: Lotensin HCT®, specification: each tablet contains 10 mg benazepril hydrochloride and 12.5 mg hydrochlorothiazide, produced by Validus Pharmaceuticals LLC) in healthy adult subjects after a single oral administration in fasting and fed state.
Secondary study objectives
To evaluate the safety of the test preparation and reference preparation of benazepril hydrochlorothiazide tablets in healthy subjects after a single oral administration.