NCT00950404已完成1 期
An Open-Label, Crossover Study In Healthy Volunteers To Evaluate The Pharmacokinetics Of Sildenafil Following Administration Of Three Orally Disintegrating Tablet Formulations Of Sildenafil 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 16 人开始时间: 2009年8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
- 16
- 试验地点
- 1
- 主要终点
- AUC0-T and Cmax of sildenafil
研究概览
简要总结
The bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •Weight: BMI from 17.5 to 30.5
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •A positive urine drug screen.
研究组 & 干预措施
Viagra 50 mg tablet, administered with water.
Active Comparator
干预措施: Viagra 50 mg tablet (Drug)
Formulation B ODT tablet 50 mg, administered without water.
Experimental
干预措施: Formulation B ODT tablet 50 mg (Drug)
Formulation C ODT tablet 50 mg, administered without water.
Experimental
干预措施: Formulation C ODT tablet 50 mg (Drug)
Formulation D ODT tablet 50 mg, administered without water.
Experimental
干预措施: Formulation D ODT tablet 50 mg (Drug)
结局指标
主要结局
AUC0-T and Cmax of sildenafil
时间窗: 1 month
次要结局
- vital signs(3 weeks)
- AUC0-Tmax and AUCinf of sildenafil(1 month)
- Tmax and half-life of sildenafil(1 month)
- laboratory parameters(3 weeks)
- adverse events(3 weeks)
研究者
研究点 (1)
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