NCT01043276已完成1 期
A Single Dose, Open, Randomized, 5-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of PF-00258210 Administered Alone Or PF-00258210 Administered Together With PF-00610355 Either As A Free Or A Fixed Dose Combination
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
- 20
- 试验地点
- 1
- 主要终点
- plasma pharmacokinetics AUClast and Cmax
研究概览
简要总结
The purpose of this study if to investiagte the time course of PF-00258210 plasma concentration in the presence or absence of PF-00610335 administered via oral inhalation using 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
- 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 subjects between the ages of 21 and 55 years, inclusive
- •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
- •Pregnant or nursing females
研究组 & 干预措施
Treatment A
Experimental
干预措施: Treatment A (Drug)
Treatment B
Experimental
干预措施: Treatment B (Drug)
Treatment C
Experimental
干预措施: Treatment C (Drug)
Treatment D
Experimental
干预措施: Treatment D (Drug)
Treatment E
Experimental
干预措施: Treatment E (Drug)
结局指标
主要结局
plasma pharmacokinetics AUClast and Cmax
时间窗: Day 1
次要结局
- plasma pharmacokinetics, AUCinf and Tmax(Day 1)
研究者
研究点 (1)
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