[Translation] A randomized, open-label, single-dose, two-formulation, two-period, double-crossover bioequivalence study of sildenafil citrate dispersible tablets in healthy subjects under fasting and fed conditions
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: Using the sildenafil citrate dispersible tablets certified by Shanghai Aoquan Biopharmaceutical Technology Co., Ltd. as the test preparation and the sildenafil citrate tablets (trade name: REVATIO®) certified by Pfizer Europe MA EEIG as the reference preparation, the pharmacokinetic behavior in healthy subjects was compared according to the relevant provisions of the bioequivalence test, and the bioequivalence of the two preparations in the fasting/postprandial state was evaluated.
Secondary purpose:
1. Evaluate the safety of the test preparation and the reference preparation after a single oral administration of the test preparation and the reference preparation in healthy subjects on an empty stomach/postprandial basis.
Collect sensory evaluation questionnaires within 15 minutes after taking the sildenafil citrate dispersible tablets (including taste, flavor, and aftertaste after administration).