[Translation] Sildenafil citrate orally disintegrating tablets single center, randomized, open, single dose, two preparations, two periods, two sequence crossover design, fasting administration human bioequivalence study
主要研究目的:研究空腹状态下单次口服受试制剂枸橼酸西地那非口崩片(规格:50 mg,由武汉海特生物制药股份有限公司生产,恒昌(广州)新药研究有限公司提供)与参比制剂枸橼酸西地那非口崩片(万艾可®,规格:50 mg;由Pfizer Limited持证,恒昌(广州)新药研究有限公司提供)在健康成年男性受试者体内的药代动力学,评价空腹状态口服两种制剂的生物等效性。
次要研究目的:研究受试制剂枸橼酸西地那非口崩片和参比制剂枸橼酸西地那非口崩片(万艾可®)在健康成年男性受试者中的安全性。
[Translation] The main purpose of the study: To study the test preparation Sildenafil Citrate Orally Disintegrating Tablets (Specification: 50 mg, produced by Wuhan Haite Biopharmaceutical Co., Ltd., Hengchang (Guangzhou) New Drug Research Co., Ltd. Provided) and the reference preparation sildenafil citrate orally disintegrating tablets (Viagra®, specification: 50 mg; licensed by Pfizer Limited, provided by Hengchang (Guangzhou) New Drug Research Co., Ltd.) in healthy adult male subjects The pharmacokinetics of the two formulations were evaluated for bioequivalence in the fasting state.
Secondary research purpose: To study the safety of the test preparation Sildenafil Citrate Orally Disintegrating Tablets and the reference preparation Sildenafil Citrate Orally Disintegrating Tablets (Viagra®) in healthy adult male subjects.