NCT00914667已完成1 期
An Open-Label, Randomized, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Fesoterodine On The Pharmacokinetics And Pharmacodynamics Of A Single Supratherapeutic Dose Of Warfarin 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
- 14
- 试验地点
- 1
- 主要终点
- Cmax and AUCinf for both S- and R-warfarin
研究概览
简要总结
This is an open-label, randomized, two-way crossover study to evaluate the steady-state effect of fesoterodine (8 mg QD) on the pharmacodynamics and pharmacokinetics of a single supratherapeutic dose of warfarin (25 mg) in healthy 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 male and/or female subjects between the ages of 18 and 55 years
排除标准
- •Not healthy subjects--subjects with acute or chronic medical or psychiatric conditions or laboratory abnormality
研究组 & 干预措施
Warfarin Alone
Experimental
Reference treatment
干预措施: warfarin (Drug)
Warfarin Concomitantly With Fesoterodine
Experimental
Test treatment
干预措施: Warfarin plus Fesoterodine (Drug)
结局指标
主要结局
Cmax and AUCinf for both S- and R-warfarin
时间窗: 8 days per period
AUC_INR and INRmax
时间窗: 8 days per period
次要结局
- AUClast, Tmax and t½ for both S- and R-warfarin(8 days per period)
- AUC_PT and PTmax(8 days per period)
- Safety will be assessed by subjective symptoms/objective findings including physical examinations, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements and adverse event monitoring.(8 days per period)
研究者
研究点 (1)
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