[Translation] A single-center, randomized study of Sildenafil Citrate Tablets developed by Jilin Cayman Pharmaceutical Co., Ltd. and Sildenafil Citrate Tablets (Viagra®) produced by Pfizer Pharmaceutical Co., Ltd. in Chinese healthy male subjects. , open-label, two-agent, fasting and postprandial, single-dose, two-cycle, double-crossover design bioequivalence study
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 Cayman Pharmaceutical Co., Ltd. were used as the test preparation, and sildenafil citrate tablets (trade name: Viagra®, Specification: 100 mg) as the reference preparation, the pharmacokinetic parameters and relative bioavailability of single administration of the two preparations in fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. The safety and tolerability of the two preparations in healthy humans were also evaluated.