A Phase 1, Cross-Over, Single-Dose, Open-Label Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-04937319 In Overweight And Obese Otherwise Healthy Subjects
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
- 2
- 主要终点
- Pf-04937319: Maximum plasma concentration (Cmax)
研究概览
简要总结
This study is designed to compare the pharmacokinetics of three different formulations of Pf-04937319
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
- •Subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28-days after the last dose of treatment.
- •Body Mass Index (BMI) of 23 to 33 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 (excluding untreated seasonal allergies).
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug screen.
结局指标
主要结局
Pf-04937319: Maximum plasma concentration (Cmax)
时间窗: 0 - 96 hours post dose
Pf-04937319: Time for Cmax (Tmax)
时间窗: 0 - 96 hours post dose
Pf-04937319: Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)
时间窗: 0 - 96 hours post dose
Pf-04937319: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
时间窗: 0 - 96 hours post dose
Pf-04937319: terminal half-life (T1/2)
时间窗: 0 - 96 hours post dose
PF-06455349: Maximum Observed Plasma Concentration (Cmax)
时间窗: 0 - 96 hours post dose
PF-06455349: Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: 0 - 96 hours post dose
PF-06455349: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
时间窗: 0 - 96 hours post dose
PF-06455349: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
时间窗: 0 - 96 hours post dose
PF-06455349: Plasma Decay Half-Life (t1/2)
时间窗: 0 - 96 hours post dose
次要结局
未报告次要终点