NCT00902460已完成1 期
A Phase 1, Randomized, 2-Way Crossover, Multiple Dose, Open Label Study Of The Effect Of CP-690,550 On Midazolam Pharmacokinetics 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
- 25
- 试验地点
- 1
- 主要终点
- AUCinf of midazolam
研究概览
简要总结
CP-690,550 and midazolam are metabolized by similar enzymes in the liver. This study is designed to assess whether co-administration of CP-690,500 and midazolam will effect the metabolism of midazolam in healthy volunteers.
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 (non-child bearing potential) subjects
排除标准
- •Clinically significant infections within the past 3 months
- •History of previously untreated infection with Mycobacterium tuberculosis
- •Positive screening test for hepatitis B surface antigen, anti-hepatitis C antibody, or human immunodeficiency virus
研究组 & 干预措施
Treatment Sequence 2
Experimental
干预措施: CP-690,550 + midazolam; midazolam (Drug)
Treatment Sequence 1
Experimental
干预措施: midazolam; CP-690,550 + midazolam (Drug)
结局指标
主要结局
AUCinf of midazolam
时间窗: 10 Days
次要结局
- AUClast, Cmax, Tmax, t1/2 of midazolam(10 Days)
- Vital signs, laboratory tests and adverse events(10 Days)
研究者
研究点 (1)
Loading locations...
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