NCT00795938已完成1 期
An Open-Label, Crossover Study In Healthy Volunteers To Evaluate The Pharmacokinetics Of Sildenafil Following Administration Of An Experimental Tablet Of Sildenafil With Or Without Water Relative To Viagra® Conventional Oral Tablet With Water.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Blood levels of sildenafil
研究概览
简要总结
This study to will compare the blood levels of sildenafil following administration of an experimental tablet vs. the conventional oral tablet.
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
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males between the ages of 18 and 55 years. Body Mass Index of 18 to 30 kg/m2, and a total body weight >50 kg (110 lbs).
排除标准
- •Smoking in excess of the equivalent of 5 cigarettes per day. Treatment with an experimental drug within 30 days or sildenafil, vardenafil, tadalfil within 4 days before first study dose.
- •Develop blood pressure lowering or experience dizziness, lightheadedness when going from the laying down position to standing position.
研究组 & 干预措施
Conventional Oral Tablet With Water
Active Comparator
干预措施: Sildenafil (Drug)
Experimental Tablet With Water
Experimental
干预措施: Sildenafil (Drug)
Experimental Tablet Without Water
Experimental
干预措施: Sildenafil (Drug)
结局指标
主要结局
Blood levels of sildenafil
时间窗: 1 day
次要结局
- Safety(1 day)
- Blood levels of a metabolite of sildenafil(1 day)
研究者
研究点 (1)
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