[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study was conducted to evaluate the bioequivalence of the test formulation of sildenafil citrate dry suspension (strength: 10 mg/mL) and the reference formulation of sildenafil citrate dry suspension (Revatio®) (strength: 10 mg/mL) in healthy adult subjects in the fasting and fed state.
主要研究目的: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干混悬剂(规格:10 mg/mL,山东朗诺制药有限公司生产)与参比制剂枸橼酸西地那非干混悬剂(Revatio®)(规格:10 mg/mL,Fareva Amboise生产)在健康受试者体内的药代动力学,评价空腹和餐后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干混悬剂(规格:10 mg/mL)和参比制剂枸橼酸西地那非干混悬剂(Revatio®)(规格:10 mg/mL)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 dry suspension (specification: 10 mg/mL, produced by Shandong Langnuo Pharmaceutical Co., Ltd.) and the reference preparation sildenafil citrate dry suspension (Revatio®) (specification: 10 mg/mL, produced by Fareva Amboise) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary purpose of the study: to evaluate the safety of the test preparation sildenafil citrate dry suspension (specification: 10 mg/mL) and the reference preparation sildenafil citrate dry suspension (Revatio®) (specification: 10 mg/mL) in healthy subjects.