[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-period, double-crossover fasting/fed bioequivalence study of sildenafil citrate orodispersible film in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂枸橼酸西地那非口溶膜(持证商:合肥华方医药科技有限公司)与参比制剂枸橼酸西地那非口溶膜(持证商:ヴィアトリス製薬株式会社,商品名:Viagra®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:观察受试制剂枸橼酸西地那非口溶膜和参比制剂枸橼酸西地那非口溶膜在健康受试者中的安全性;评价受试制剂枸橼酸西地那非口溶膜和参比制剂枸橼酸西地那非口溶膜的适口性(整体口感、异味、甜度、香气、苦味评价)、砂砾感、溶化时间、黏膜粘附性和刺激性。
[Translation] Main objective: Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behavior of the test preparation sildenafil citrate orodispersible film (licensed by: Hefei Huafang Pharmaceutical Technology Co., Ltd.) and the reference preparation sildenafil citrate orodispersible film (licensed by: Viatris Pharmaceutical Co., Ltd., trade name: Viagra®) in healthy subjects after oral administration in the fasting/postprandial state was compared, and the bioequivalence of the two preparations was evaluated.
Secondary objectives: To observe the safety of the test sildenafil citrate oral dissolving film and the reference sildenafil citrate oral dissolving film in healthy subjects; to evaluate the palatability (overall taste, peculiar smell, sweetness, aroma, bitterness evaluation), grittiness, dissolution time, mucosal adhesion and irritation of the test sildenafil citrate oral dissolving film and the reference sildenafil citrate oral dissolving film.