临床试验/NCT01185184

NCT01185184已完成1 期

A Phase 1, Randomized, 3-Period, Open Label, Single Dose, Cross Over Study To Evaluate The Pharmacokinetics And Safety Of Two Controlled Release Formulations Of CP-690,550

Pfizer1 个研究点分布在 1 个国家目标入组 12 人开始时间: 2010年8月最近更新: 2010年9月14日

适应症

干预措施

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: Pharmacokinetic parameters: AUCinf(dn), Frel and Cmax(dn) of CP-690,550

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will explore the drug behavior and safety following single dose of two 20 milligram CP-690,550 osmotic capsules in 12 healthy volunteers. These will be compared to a 10 milligram immediate release tablet, using a 3 way crossover design.

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 Months 至 55 Years（Child, Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy male and/or female subjects

排除标准

•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
•Clinically significant infections within the past 3 months.

研究组 & 干预措施

1

Experimental

Subjects will receive in random order, the immediate release tablet containing 10 mg of CP-690,550 and two different controlled-release capsules containing 20 mg of CP-690,550.

干预措施: CP-690,550 (Drug)

结局指标

主要结局

Pharmacokinetic parameters: AUCinf(dn), Frel and Cmax(dn) of CP-690,550

时间窗: 36 hours

次要结局

Pharmacokinetic parameters: AUCinf, AUClast, AUClast(dn), Cmax, Tmax, t½, C12h, C24h of CP-690,550(9 days)
Safety: laboratory tests, adverse events reporting, ECG and vital signs(9 days)

研究者

发起方

Pfizer

申办方类型

Industry

研究点 (1)

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