[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(生产厂家:上海欣峰制药有限公司)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 purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the oral administration of the test preparation sildenafil citrate orally dissolvable film (manufacturer: Shanghai Xinfeng Pharmaceutical Co., Ltd.) and The pharmacokinetic behavior of the reference preparation sildenafil citrate after oral dissolution in film (licensee: Viagra® Co., Ltd., trade name: Viagra®) was evaluated in vivo to evaluate the biological properties of the two preparations. Equivalence.
Secondary purpose: To observe the safety of the test preparation sildenafil citrate orally dissolving film and the reference preparation sildenafil citrate orally dissolving film in healthy subjects; to evaluate the test preparation sildenafil citrate orally dissolving film Palatability (overall taste, off-flavor, sweetness, aroma, bitterness evaluation), gritty feeling, dissolution time, mucoadhesion and irritation of the orally dissolvable film of denafil and the reference preparation sildenafil citrate orally dissolvable film sex.