[Translation] An open, randomized, single-dose, two-formulation, single-dose, two-period, two-sequence, double-crossover bioequivalence study of sildenafil citrate orodispersible film (specification: 50 mg) in healthy subjects under fasting and fed conditions
研究空腹和餐后状态下单次口服受试制剂枸橼酸西地那非口溶膜(规格:50mg,浙江和泽医药科技股份有限公司提供)与参比制剂枸橼酸西地那非口溶膜(商品名:万艾可®,规格:50mg,ヴィアトリス製薬株式会社持证)在健康成年受试者体内的药代动力学,评价空腹和餐后口服两种制剂的生物等效性。
[Translation] Study the single oral administration of the test preparation sildenafil citrate oral dissolving film (specification: 50 mg, provided by Zhejiang Heze Pharmaceutical Technology Co., Ltd.) and the reference preparation sildenafil citrate oral administration in fasting and postprandial states. Pharmacokinetics of dissolved film (trade name: Viagra®, specification: 50 mg, licensed by Biotech Co., Ltd.) in healthy adult subjects, and the bioequivalence of the two preparations taken orally on an empty stomach and after a meal was evaluated.