[Translation] A single-center, randomized, open-label, two-dose, fasting and postprandial, single-dose, two-period, double-crossover bioequivalence study of the developed tadalafil tablets and the original reference formulation in healthy Chinese male subjects
以研制的他达拉非片(规格:20 mg)为受试制剂,生产厂为美国礼来公司的他达拉非片(希爱力,规格:20 mg)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] The developed tadalafil tablets (specification: 20 mg) were used as the test preparation, and the tadalafil tablets (Cialis, specification: 20 mg) produced by Eli Lilly and Company of the United States were 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.