[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of enalapril maleate tablets produced by Hebei Dongfeng Pharmaceutical Co., Ltd. and enalapril maleate tablets (trade name: Renitec®) produced by Merck Sharp & Dohme B.V. in healthy Chinese subjects under fasting and fed conditions
以河北东风药业有限公司生产的马来酸依那普利片(规格:10 mg)为受试制剂,Merck Sharp & Dohme B.V.生产的马来酸依那普利片(商品名:Renitec®,规格10mg)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性;同时评价两种制剂在健康人体中的安全性和耐受性。
[Translation] Enalapril Maleate Tablets (Specification: 10 mg) produced by Hebei Dongfeng Pharmaceutical Co., Ltd. was used as the test preparation, and Enalapril Maleate Tablets (Trade Name: Renitec®, Specification: 10 mg) produced by Merck Sharp & Dohme B.V. was used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent; at the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.