NCT01254383已完成1 期
An Open Label Crossover Study In Healthy Older Male Subjects To Evaluate The Pharmacokinetics And Safety Of Sildenafil Following Fasted Administration Of An Orally Disintegrating Tablet Formulation Of Sildenafil Administered With Or Without Water Relative To Viagra® 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 36 人开始时间: 2010年12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
- 36
- 试验地点
- 1
- 主要终点
- AUC(0-t) of sildenafil.
研究概览
简要总结
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.
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 and dated informed consent document.
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
Treatment A
Active Comparator
Viagra 50 mg tablet, administered with approximately 240 mL water under fasted conditions
干预措施: Sildenafil Tablet (Drug)
Treatment B
Experimental
Sildenafil ODT tablet 50 mg, administered without water under fasted conditions
干预措施: Sildenafil ODT (Drug)
Treatment C
Experimental
Sildenafil ODT tablet 50 mg, administered with water under fasted conditions.
干预措施: Sildenafil ODT (Drug)
结局指标
主要结局
AUC(0-t) of sildenafil.
时间窗: Up to 1 month
Cmax of sildenafil.
时间窗: Up to 1 month
次要结局
- Half-life of sildenafil, if data permits.(Up to 1 month)
- AUC(0-inf) of sildenafil, if data permits.(Up to 1 month)
- Number of patients with adverse events.(Up to 1 month)
- Tmax of sildenafil.(Up to 1 month)
研究者
研究点 (1)
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