[Translation] Single-center, open, randomized, single-dose, double-period, double-crossover bioequivalence study of tadalafil tablets in healthy adult male subjects under fasting and fed states
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] main purpose
Comparison of Tadalafil Tablets (Specification: 20mg) provided by Beijing Huicheng Ruixiang Pharmaceutical Biotechnology Co., Ltd. and Tadalafil Tablets (Specification: 20mg; commercial product) licensed by Eli Lilly Nederland B.V. Name: Cialis® (Cialis®) in healthy adult male population differences in the degree and speed of absorption, to evaluate its bioequivalence.
secondary purpose
Evaluation of tadalafil tablets (specification: 20mg) provided by Beijing Huicheng Ruixiang Pharmaceutical Biotechnology Co., Ltd. and Tadalafil tablets (specification: 20mg; commodity Name: Cialis ® (Cialis ®) safety.