[Translation] A randomized, open-label, two-drug, fasting/postprandial, single-dose, two-cycle, double-crossover bioequivalence trial of sildenafil citrate tablets (100 mg) in healthy male volunteers
主要目的:是以常山生化药业(江苏)有限公司生产的枸橼酸西地那非片(100mg)为受试制剂,以辉瑞制药有限公司生产的枸橼酸西地那非片(100mg,万艾可)为参比制剂,评估健康男性志愿者在空腹和餐后状态下单次口服受试制剂和参比制剂的相对生物利用度,评价两制剂的生物等效性。次要目的:评估受试制剂和参比制剂在健康男性志愿者中的安全性。
[Translation] Main purpose: Take Sildenafil Citrate Tablets (100mg) produced by Changshan Biochemical Pharmaceutical (Jiangsu) Co., Ltd. as the test preparation, and take Sildenafil Citrate Tablets (100mg, Viagra) was used as the reference preparation to evaluate the relative bioavailability of the test preparation and the reference preparation in a single oral dose of healthy male volunteers in fasting and postprandial states, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of test and reference products in healthy male volunteers.