NCT00911235已完成1 期
An Open-Label, Randomized, Two-Way Crossover Study To Evaluate The Effect Of Fluconazole, A Moderate CYP3A4 Inhibitor, On The Single-Dose Pharmacokinetics Of Fesoterodine In Healthy Subjects.
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
- Pfizer
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- AUCinf and Cmax of 5-HMT
研究概览
简要总结
This study is designed to estimate the effect of fluconazole (200 mg BID for 2 days), a moderate CYP3A4 inhibitor on the pharmacokinetics of a single 8 mg oral dose of fesoterodine in healthy adult subjects.
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
- 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 between the ages of 18 and 55 years
排除标准
- •Not healthy subjects. subjects with acute or chronic medical or psychiatric condition or laboratory abnormality
研究组 & 干预措施
Fesoterodine Alone
Experimental
Reference treatment
干预措施: Fesoterodine (Drug)
fesoterodine plus fluconazole
Other
Test treatment
干预措施: fesoterodine plus fluconazole (Drug)
结局指标
主要结局
AUCinf and Cmax of 5-HMT
时间窗: 3 days per period
次要结局
- AUClast, Tmax and half-life of 5-HMT as data permit.(3 days per period)
- Safety will be assessed by subjective symptoms/objective findings including physical examination findings, clinical safety laboratory assessments and adverse event monitoring.(3 days per period)
研究者
研究点 (1)
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