[Translation] A single-center, randomized, open-label, two-dose, fasting and postprandial, single-dose, two-period, double-crossover bioequivalence study of sildenafil citrate tablets developed by Jilin Kaiman Pharmaceutical Co., Ltd. and sildenafil citrate tablets (Viagra®) produced by Pfizer Pharmaceuticals Co., Ltd. in healthy Chinese male subjects
以吉林开曼药业有限公司研制的枸橼酸西地那非片(规格:100 mg)为受试制剂,辉瑞制药有限公司生产的枸橼酸西地那非片(商品名:万艾可®,规格:100 mg)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。同时评价两制剂在健康人体中的安全性和耐受性。
[Translation] Sildenafil citrate tablets (specification: 100 mg) developed by Jilin Kaiman Pharmaceutical Co., Ltd. were used as the test preparation, and Sildenafil citrate tablets (trade name: Viagra®, specification: 100 mg) produced by Pfizer Pharmaceuticals Co., Ltd. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.