[Translation] An open, randomized, single-dose, two-formulation, two-period, two-sequence crossover bioequivalence study of sildenafil citrate orodisintegrating tablets in healthy male subjects under fasting condition
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,四川省旭晖制药有限公司生产)与参比制剂枸橼酸西地那非口崩片(Viagra®)(规格:50 mg,Fareva Amboise生产)在健康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:评估受试制剂枸橼酸西地那非口崩片(规格:50 mg)和参比制剂枸橼酸西地那非口崩片(Viagra®)(规格:50 mg)在健康受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation sildenafil citrate orodisintegrating tablets (specification: 50 mg, produced by Sichuan Xuhui Pharmaceutical Co., Ltd.) and the reference preparation sildenafil citrate orodisintegrating tablets (Viagra®) (specification: 50 mg, produced by Fareva Amboise) in healthy subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting conditions.
The secondary purpose of the study is to evaluate the safety of the test preparation sildenafil citrate orodisintegrating tablets (specification: 50 mg) and the reference preparation sildenafil citrate orodisintegrating tablets (Viagra®) (specification: 50 mg) in healthy subjects.