NCT01166217已完成1 期
A Phase 1, Cross-over, Single-dose, Open-label Study to Estimate the Relative Bioavailability of Three Different Formulations of Pf-04620110 Under Fed/Fasted Conditions in Healthy Adult Subjects
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
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, C24hr, peak trough ratio (PTR), and half life
研究概览
简要总结
PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the relative bioavailability of three different oral dose formulations of PF-04620110.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
研究组 & 干预措施
ABCE, ACBD, BACD, BCAE, CABE and CBAD
Experimental
干预措施: PF-04620110 (Drug)
结局指标
主要结局
Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, C24hr, peak trough ratio (PTR), and half life
时间窗: following each treatment
次要结局
- Safety Endpoints: Safety and tolerability of PF 04620110 will be assessed by physical examinations, adverse event monitoring, 12 lead electrocardiograms (ECGs), vital signs, and clinical safety laboratory measurements.(before, during and following treatment)
研究者
研究点 (1)
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