NCT01469468已完成1 期
A Phase 1, Open-Label, Fixed-Sequence Study To Estimate The Effect Of Repeated Dosing Of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin 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
- 14
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration curve of simvastatin and simvastatin acid
研究概览
简要总结
The study is designed to investigate the effect of repeated dosing of PF-05175157 on the pharmacokinetics of a single dose of Simvastatin in healthy adult subjects.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects with normal results in all screening examinations.
- •Body Mass Index of 17.5 to 35.5 kg/m2
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, ocular, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Known history of intolerance to simvastatin or other statins.
研究组 & 干预措施
Single arm, fixed sequence dosing
Experimental
干预措施: Simvastatin (Drug)
Single arm, fixed sequence dosing
Experimental
干预措施: PF-05175157 (Drug)
结局指标
主要结局
Area under the plasma concentration curve of simvastatin and simvastatin acid
时间窗: 10 days
If the data permit, area under the plasma concentration curve of simvastatin and simvastatin acid extrapolated to infinite time
时间窗: 10 days
Maximum observed plasma concentration of simvastatin and simvastatin acid
时间窗: 10 days
Time at which maximum plasma concentration of simvastatin and simvastatin acid is observed
时间窗: 10 days
If the data permit, terminal elimination half-life of simvastatin and simvastatin acid
时间窗: 10 days
次要结局
未报告次要终点
研究者
研究点 (1)
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