NCT00444548已完成不适用
Measurement Of Urethral Function In Healthy Female Volunteers - Evaluation Of The Sensitivity of Urethral Reflectometry Compared To Urethral Pressure Profilometry, Using [S,S]-Reboxetine.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Reflectometry measurements at visit 2, 3, 4 , 5, 6 and 7.
研究概览
简要总结
[S,S]-Reboxetine will be used to evaluate pharmacodynamic changes in urethral function in healthy volunteers using a novel methodology
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects, aged 18-65 years.
- •Subjects must be non-pregnant and non-lactating, and be either post menopausal (greater than 1 year without menses), surgically sterilized, or using another acceptable form of contraception.
- •Subjects of child bearing potential must have confirmed negative pregnancy tests at screening and prior to commencing all study periods.
排除标准
- •Evidence or history of clinically significant disease (including drug allergies, but excluding untreated, asymptomatic,seasonal allergies at time of dosing).
- •Subjects with any clinically significant abnormality following review of laboratory data, urinalysis and physical examination.
结局指标
主要结局
Reflectometry measurements at visit 2, 3, 4 , 5, 6 and 7.
次要结局
- Urethral pressure profile measurements at visit 2, 3, 4, 5, 6 and 7
研究者
研究点 (2)
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