[Translation] Randomized, open, single-dose, two-dose, two-period, double-crossover bioequivalence study of sildenafil citrate dispersible tablets in healthy subjects under fasting and fed states
主要目的:以上海奥全生物医药科技有限公司持证的枸橼酸西地那非分散片为受试制剂,以Pfizer Europe MA EEIG持证的枸橼酸西地那非片(商品名:REVATIO®)为参比制剂,按生物等效性试验的相关规定,比较在健康受试者体内的药代动力学行为,评价空腹/餐后状态两种制剂的生物等效性。
次要目的:
1.评价健康受试者单次空腹/餐后口服受试制剂和参比制剂后的安全性。
收集受试者服用枸橼酸西地那非分散片后15min内的感官评估问卷(包含口感、口味以及给药后的余味)。
[Translation] Main purpose: to use Sildenafil Citrate Dispersible Tablets licensed by Shanghai Aoquan Biomedical Technology Co., Ltd. as the test preparation, and Sildenafil Citrate Tablets licensed by Pfizer Europe MA EEIG (trade name: REVATIO ®) as the reference preparation, according to the relevant provisions of the bioequivalence test, compare the pharmacokinetic behavior in healthy subjects, and evaluate the bioequivalence of the two preparations in the fasting/fed state.
Secondary purpose:
1. Evaluate the safety of healthy subjects after a single oral administration of the test preparation and the reference preparation on an empty stomach/after a meal.
The sensory evaluation questionnaires (including mouthfeel, taste and aftertaste after administration) within 15 minutes after subjects took sildenafil citrate dispersible tablets were collected.