[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study of tadalafil tablets in healthy adult male subjects under fasting and fed conditions
主要目的
比较空腹和餐后给药条件下,北京汇诚瑞祥医药生物科技有限公司提供的他达拉非片(规格:20mg)与Eli Lilly Nederland B.V.持证的他达拉非片(规格:20mg;商品名:希爱力®(Cialis®))在健康成年男性人群中吸收程度和速度的差异,评价其生物等效性。
次要目的
评价空腹和餐后给药条件下,北京汇诚瑞祥医药生物科技有限公司提供的他达拉非片(规格:20mg)与Eli Lilly Nederland B.V.持证的他达拉非片(规格:20mg;商品名:希爱力®(Cialis®))的安全性。
[Translation] Primary objective
To compare the differences in the extent and rate of absorption of tadalafil tablets (specification: 20 mg) provided by Beijing Huicheng Ruixiang Pharmaceutical Biotechnology Co., Ltd. and tadalafil tablets (specification: 20 mg; trade name: Cialis®) licensed by Eli Lilly Nederland B.V. in healthy adult males under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary objective
To evaluate the safety of tadalafil tablets (specification: 20 mg) provided by Beijing Huicheng Ruixiang Pharmaceutical Biotechnology Co., Ltd. and tadalafil tablets (specification: 20 mg; trade name: Cialis®) licensed by Eli Lilly Nederland B.V. under fasting and postprandial administration conditions.