[Translation] A human bioequivalence study of benazepril and hydrochlorothiazide tablets in Chinese healthy subjects in a single-center, randomized, open-label, two-period, self-crossover, single-dose fasting administration and a single-center, randomized, open-label, three-period partially repeated, self-crossover, single-dose postprandial administration
主要目的:采用单中心、随机、开放、双周期、自身交叉、单剂量空腹给药设计及单中心、随机、开放、三周期部分重复、自身交叉、单剂量餐后给药设计,比较空腹及餐后条件下,维生原(厦门)生物科技有限公司提供的贝那普利氢氯噻嗪片(规格:10 mg/12.5 mg)与Validus Pharmaceuticals LLC 持证生产的贝那普利氢氯噻嗪片(商品名:Lotensin HCT®,规格:10 mg/12.5mg)在中国健康人群中吸收程度和吸收速度的差异,评价两制剂的生物等效性。
次要目的:评价维生原(厦门)生物科技有限公司提供的贝那普利氢氯噻嗪片的安全性。
[Translation] 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.