[Translation] To evaluate the effect of the test preparation sildenafil citrate oral dissolving film (specification: 50 mg) and the reference preparation sildenafil citrate tablet (Viagra®, specification: 50 mg) on the diet of Chinese healthy adult male subjects. Single-center, open-label, randomized, single-dose, three-period, six-sequence, crossover bioequivalence study in post-state
主要试验目的:研究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:50 mg,Kyukyu Pharmaceutical Co. Ltd.生产)(用水或不用水服用)与参比制剂枸橼酸西地那非片(万艾可®,规格:50 mg;辉瑞制药有限公司生产)(用水服用)在中国健康男性受试者体内的药代动力学特征,评价餐后状态口服两种制剂的生物等效性。
次要试验目的:研究受试制剂枸橼酸西地那非口溶膜(规格:50 mg)和参比制剂枸橼酸西地那非片(万艾可®,规格:50 mg)在中国健康男性受试者中的安全性。
[Translation] The main purpose of the test: To study the single oral administration of the test preparation Sildenafil Citrate Oral Dissolving Film (Specification: 50 mg, produced by Kyukyu Pharmaceutical Co. Ltd.) (taken with or without water) and the reference preparation in the postprandial state Pharmacokinetic characteristics of sildenafil citrate tablets (Viagra®, specification: 50 mg; produced by Pfizer Pharmaceuticals Co., Ltd.) (administered with water) in Chinese healthy male subjects, evaluating the oral administration of two preparations in the postprandial state bioequivalence.
Secondary test purpose: To study the effect of the test preparation sildenafil citrate oral dissolving film (specification: 50 mg) and the reference preparation sildenafil citrate tablet (Viagra®, specification: 50 mg) in Chinese healthy men Safety in subjects.