[Translation] A single-center, open-label, randomized, single-dose, double-cycle, double-crossover fasting and postprandial bioequivalence trial of Sildenafil Citrate Tablets in healthy subjects.
主要目的
比较空腹和餐后给药条件下,山东华铂凯盛生物科技有限公司提供的枸橼酸西地那非片(100 mg)与辉瑞制药有限公司持证的枸橼酸西地那非片(100 mg,商品名:万艾可®)在健康成年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,山东华铂凯盛生物科技有限公司提供的枸橼酸西地那非片(100 mg)与辉瑞制药有限公司持证的枸橼酸西地那非片(100 mg,商品名:万艾可®)在健康成年人群中的安全性。
[Translation] main purpose
Comparing fasting and postprandial administration conditions, Sildenafil Citrate Tablets (100 mg) provided by Shandong Huabo Kaisheng Biotechnology Co., Ltd. and Sildenafil Citrate Tablets (100 mg) licensed by Pfizer Pharmaceutical Co., Ltd. 100 mg, trade name: Viagra®) in the healthy adult population, to evaluate the differences in the degree and rate of absorption and to evaluate its bioequivalence.
secondary purpose
To evaluate the results of fasting and postprandial administration conditions, Sildenafil Citrate Tablets (100 mg) provided by Shandong Huabo Kaisheng Biotechnology Co., Ltd. and Sildenafil Citrate Tablets (100 mg) licensed by Pfizer Pharmaceuticals Co., Ltd. 100 mg, trade name: Viagra®) in healthy adults.