NCT00862667已完成1 期
An Open Study To Estimate The Plasma Pharmacokinetics Of PF-00241939 Administered Via Oral Inhalation Using Dry Powder Inhalers.
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
- Plasma pharmacokinetic parameters: AUClast & Cmax.
研究概览
简要总结
The purpose of this study is to investigate the time course of PF-00241939 concentration in the blood following dosing by oral inhalation from dry powder inhalers.
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
- 21 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 21 and 55 years.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •A positive urine drug screen.
- •History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
- •Pregnant or nursing females.
研究组 & 干预措施
Treatment A
Experimental
PF-00241939 300ug using Inhaler A
干预措施: Treatment A (Drug)
Treatment B
Active Comparator
PF-00241939 300ug using Inhaler B
干预措施: Treatment B (Drug)
Treatment C
Active Comparator
PF-00241939 300ug using Inhaler C
干预措施: Treatment C (Drug)
结局指标
主要结局
Plasma pharmacokinetic parameters: AUClast & Cmax.
时间窗: 48 hours
次要结局
- Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and t½.(48 hours)
研究者
研究点 (1)
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