[Translation] A single-center, open-label, randomized, single-dose crossover bioequivalence study of WYH-062 in healthy subjects under fasting and fed conditions
1.主要目的
比较空腹和餐后给药条件下,湘北威尔曼制药股份有限公司提供的盐酸伐地那非片(20mg)与Bayer AG持证的盐酸伐地那非片(20mg,商品名:Levitra®)在健康成年男性中吸收程度和速度的差异,评价其生物等效性。
2.次要目的
评价空腹和餐后给药条件下,湘北威尔曼制药股份有限公司提供的盐酸伐地那非片(20mg)与Bayer AG持证的盐酸伐地那非片(20mg,商品名:Levitra®)在健康成年男性中的安全性。
[Translation] 1. Primary Objective
To compare the extent and rate of absorption of vardenafil hydrochloride tablets (20 mg) supplied by Xiangbei Wellman Pharmaceutical Co., Ltd. and vardenafil hydrochloride tablets (20 mg, trade name: Levitra®) licensed by Bayer AG in healthy adult males under fasting and fed conditions, and to evaluate their bioequivalence.
2. Secondary Objective
To evaluate the safety of vardenafil hydrochloride tablets (20 mg) supplied by Xiangbei Wellman Pharmaceutical Co., Ltd. and vardenafil hydrochloride tablets (20 mg, trade name: Levitra®) licensed by Bayer AG in healthy adult males under fasting and fed conditions.