Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Study Assessing Bioequivalence Of Sildenafil 50 Mg Orally-Disintegrating Tablet With Or Without Water To Viagra® 50 Mg Oral Tablet With Water Under Fasted Condition
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
研究概览
简要总结
The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under fasted conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese male subjects between the ages of 20 and 55 years.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
排除标准
- •Baseline orthostatic hypotension defined as a >=20 mm Hg reduction in systolic blood pressure (SBP), a >=10 mm Hg reduction in diastolic blood pressure (DBP) or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position.
- •Subjects who are currently prescribed or taking nitrates or nitric oxide donors in any form on either a regular or intermittent basis.
研究组 & 干预措施
Viagra
Oral tablet of sildenafil citrate (Japanese commercial tablet: Viagra® tablet) 50 mg as a single oral dose under fasted conditions
干预措施: Viagra (Drug)
ODT without water
Sildenafil ODT 50 mg without water as a single oral dose under fasted conditions
干预措施: sildenafil ODT (Drug)
ODT with water
Sildenafil ODT 50 mg with water as a single oral dose under fasted conditions
干预措施: sildenafil ODT (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
时间窗: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose)
- Maximum Observed Plasma Concentration (Cmax)(0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(9 days)
- 12-lead electrocardiogram (ECG)(9 days)
- Pulse rate (PR)(9 days)
- Number of Participants With Laboratory Test Values of Potential Clinical Importance(9 days)
- Mean Residence Time(MRT)(0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)](0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose)
- Plasma Decay Half-Life (t1/2)(0, 0.05, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 h post-dose)
- Diastolic and Systolic Blood Pressure(9 days)