An Open Label Crossover Study In Healthy Older Male Subjects To Evaluate The Pharmacokinetics And Safety Of An Orally Disintegrating Tablet Formulation Of Sildenafil Administered Without Water Under Fed Compared To Fasted Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Otherwise healthy male subjects age 45 years or older with or without erectile dysfunction.
- •Body Mass Index (BMI) of 17.5 to 32.5 kg/m
- •Signed Informed Consent.
排除标准
- •Evidence or history of clinically significant abnormalities
- •Have baseline orthostatic hypotension
- •Positive drug screen, excessive alcohol and tobacco use
研究组 & 干预措施
Sildenafil ODT tablet 50 mg, Fasted
Treatment A: Sildenafil ODT tablet 50 mg, administered without water under fasted conditions.
干预措施: Sildenafil (Drug)
Sildenafil ODT tablet 50 mg, Fed
Treatment B: Sildenafil ODT tablet 50 mg, administered without water under fed conditions.
干预措施: Sildenafil (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
时间窗: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours (hrs) post-dose
Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).
次要结局
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)](0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose)
- Plasma Decay Half Life (t1/2)(0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose)