临床试验/NCT01119235

NCT01119235已完成1 期

A Phase 1, Open Label Study To Investigate The Pharmacokinetics Of Multiple Doses Of PF-04531083 Tablets In Healthy Volunteers

Pfizer1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2010年5月最近更新: 2010年8月6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: 24
试验地点: 1
主要终点: concentration of PF-04531083 in blood just before dosing on the 8th day of the study

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

A new tablet form of PF-04531083 has been manufactured. Previously the compound was administered as a solution/suspension to healthy volunteers. This study will investigate the pharmacokinetics of PF-044531083 in tablet form and compare with the pharmacokinetics obtained, with the same dosing regimen, with the solution/suspension.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy volunteers

排除标准

•Elderly volunteers
•Patients with any existing medical conditions considered likely to impinge on study execution

研究组 & 干预措施

Cohort 2: PF-04531083

Active Comparator

干预措施: PF-04531083 (Drug)

Cohort 1: PF-04531083

Active Comparator

干预措施: PF-04531083 (Drug)

结局指标

主要结局

concentration of PF-04531083 in blood just before dosing on the 8th day of the study

时间窗: Days 1 and 8 of the study

次要结局

pharmacokinetic parameters derived from the plasma concentration versus time profile of PF-04531083 following single and multiple dosing. AUCtau, Cmax, Tmax will be calculated.(Days 1, 8 and 14 of the study)

研究者

发起方

Pfizer

申办方类型

Industry

研究点 (1)

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