Benazepril Hydrochloride/Hydrochlorothiazide

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.

Primary objective: To compare the differences in the absorption extent and absorption rate of benazepril hydrochlorothiazide tablets (specification: 10 mg/12.5 mg) provided by Weishengyuan (Xiamen) Biotechnology Co., Ltd. and benazepril hydrochlorothiazide tablets (trade name: Lotensin HCT®, specification: 10 mg/12.5 mg) produced by Validus Pharmaceuticals LLC under fasting and postprandial conditions in healthy Chinese population by using a single-center, randomized, open, two-period, self-crossover, single-dose fasting administration design and a single-center, randomized, open, three-period partially repeated, self-crossover, single-dose postprandial administration design, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of benazepril hydrochlorothiazide tablets provided by Weishengyuan (Xiamen) Biotechnology Co., Ltd.