NCT00914641已完成1 期
A Randomized, Open-Label, Single Dose, Four Way Cross-Over Bioavailability Study Comparing Three Modified Release Formulations Of Apixaban Tablets To Apixaban Immediate Release Tablets In Healthy Volunteers
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
- 16
- 试验地点
- 1
- 主要终点
- Apixaban PK: Cmax, C24, AUClast, AUCinf, Tmax, and half-life (t½)
研究概览
简要总结
To estimate the pharmacokinetics of apixaban when administered as three different modified release formulation tablets relative to that when apixaban is administered as an immediate release tablet
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female patients
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
排除标准
- •Any condition possibly affecting drug absorption
- •History or evidence of abnormal bleeding or clotting disorder
研究组 & 干预措施
Apixaban Cross-over
Other
干预措施: Apixaban MR3 (Drug)
Apixaban Cross-over
Other
干预措施: Apixaban MR2 (Drug)
Apixaban Cross-over
Other
干预措施: Apixaban MR1 (Drug)
Apixaban Cross-over
Other
干预措施: Apixaban IR (Drug)
结局指标
主要结局
Apixaban PK: Cmax, C24, AUClast, AUCinf, Tmax, and half-life (t½)
时间窗: 96 hours
Safety and tolerability as determined by adverse event reporting, clinical laboratory results, vital signs, physical examinations, and ECGs.
时间窗: per treatment period of 96 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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