[Translation] Randomized, open-label, two-cycle, double-crossover bioequivalence study of sildenafil citrate tablets in healthy human subjects in fasting state
以南昌立健药业有限公司生产的枸橼酸西地那非片为受试制剂,以Pfizer Pharmaceuticals LLC生产的Viagra ®为参比制剂,考察两制剂在健康人体空腹状态下单次给药的吸收速度和吸收程度的差异,以此计算两制剂之间的相对生物利用度,评价两制剂在空腹状态下是否具有生物等效性。
[Translation] Taking sildenafil citrate tablets produced by Nanchang Lijian Pharmaceutical Co., Ltd. as the test preparation, and Viagra ® produced by Pfizer Pharmaceuticals LLC as the reference preparation, the effects of single administration of the two preparations in healthy human subjects on an empty stomach were investigated. The difference in absorption rate and degree of absorption was used to calculate the relative bioavailability between the two preparations, and to evaluate whether the two preparations had bioequivalence in the fasting state.