NCT01186757已完成1 期
A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Inhaled Doses Of PF-03715455 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
- 36
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of single and multiple inhaled doses of PF-03715455, as measured by plasma concentrations - Cmax, Tmax, AUCtau, t½, accumulation ratio (Rac, Rss, Rac,Cmax).
研究概览
简要总结
Evaluation of the multiple dose pharmacokinetics of PF-3715455 in healthy volunteers
详细描述
Healthy volunteer PK study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
排除标准
- •Standard healthy volunteer criteria
研究组 & 干预措施
PF-03715455 4 mg BID
Active Comparator
干预措施: PF-03715455 (Drug)
PF-03715455 10 mg BID
Active Comparator
干预措施: PF-03715455 (Drug)
PF-03715455 1.6mg BID
Active Comparator
干预措施: PF-03715455 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetics of single and multiple inhaled doses of PF-03715455, as measured by plasma concentrations - Cmax, Tmax, AUCtau, t½, accumulation ratio (Rac, Rss, Rac,Cmax).
时间窗: 17 days
次要结局
- Safety and toleration as measured by adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.(28 Days)
研究者
研究点 (1)
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