[Translation] A randomized, open-label, single-dose, two-formulation, three-sequence, three-period, partially repeated crossover bioequivalence study of benazepril hydrochloride tablets in healthy volunteers after meals
比较餐后单次给药条件下,上海新亚药业闵行有限公司生产的盐酸贝那普利片(规格:10mg,受试制剂)与MEDA Pharma GmbH & Co. KG生产的盐酸贝那普利片(规格:10mg,参比制剂)在健康受试者中吸收程度和速度的差异。通过主要药代动力学参数,评价两者是否生物等效,为受试制剂的注册申请提供依据。通过观察安全性指标,评价盐酸贝那普利片的安全性。
[Translation] To compare the differences in absorption extent and rate of Benazepril Hydrochloride Tablets (Specification: 10 mg, test preparation) produced by Shanghai Xinya Pharmaceutical Minhang Co., Ltd. and Benazepril Hydrochloride Tablets (Specification: 10 mg, reference preparation) produced by MEDA Pharma GmbH & Co. KG in healthy subjects under the condition of single administration after meal. The main pharmacokinetic parameters were used to evaluate whether the two were bioequivalent, providing a basis for the registration application of the test preparation. The safety of Benazepril Hydrochloride Tablets was evaluated by observing safety indicators.