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临床试验/NCT01043276
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

Pfizer1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年1月最近更新:
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

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

发起方
Pfizer
申办方类型
Industry

研究点 (1)

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