NCT00987038已完成1 期
A Phase 1, Open Label, Multiple Dose Study Of The Effect Of PF-04171327 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
- 12
- 试验地点
- 1
- 主要终点
- AUCinf of midazolam
研究概览
简要总结
The purpose of this study is to investigate the effects of multiple doses of PF-04171327 on the blood levels (pharmacokinetics) of midazolam
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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 males and/or females (non-childbearing potential) volunteers.
- •Cortisol level within normal reference range of the laboratory.
排除标准
- •History of intolerance or significant adverse effect with glucocorticoid (steroid) therapy.
- •History or current positive results for HIV, Hepatitis B or C or active TB or currently undergoing treatment for TB.
- •Known history of hypersensitivity, allergy severe drug reaction or unable to tolerate midazolam or other benzodiazepines.
研究组 & 干预措施
PF-04171327 and Midazolam
Other
干预措施: PF-04171327 25 mg (Drug)
PF-04171327 and Midazolam
Other
干预措施: Midazolam 2 mg (Drug)
结局指标
主要结局
AUCinf of midazolam
时间窗: 17 days
次要结局
- AUClast, Cmax, Tmax, t1/2(17 days)
- Vital Signs, Clinical Laboratory tests and Adverse Events(28 days)
研究者
研究点 (1)
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