[Translation] A single-center 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 Chinese healthy subjects , randomized, open-label, single-dose, two-cycle, double-crossover fasting and postprandial bioequivalence study
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. were used as the test preparation, and enalapril maleate tablets (trade name: Renitec®, produced by Merck Sharp & Dohme B.V. Specification: 10 mg) is used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration under fasting and postprandial conditions are examined to evaluate whether the two preparations are bioequivalent; and the two preparations are evaluated simultaneously. Safety and tolerability in healthy humans.