NCT01103739已完成1 期
A Phase 1, Open Label, Fixed Sequence Study To Investigate The Effect Of Multiple Doses Of PF-04531083 On Simvastatin And Simvastatin Acid Pharmacokinetics Following Single Dose Of Simvastatin in Healthy Volunteers
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
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of simvastatin. AUC, Cmax and half life.
研究概览
简要总结
The purpose of this study is to quantify the effect of multiple doses of PF-04531083 on the pharmacokinetics (PK) of co-administered single dose simvastatin.
详细描述
observational- quantify any effects of PF_04531083 on the PK of Simvastatin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •male and female volunteers
排除标准
- 未提供
研究组 & 干预措施
cohort 1
Experimental
干预措施: PF-04531083 (Drug)
cohort 1
Experimental
干预措施: simvastatin (Drug)
cohort 2
Experimental
干预措施: PF-04531083 (Drug)
cohort 2
Experimental
干预措施: simvastatin (Drug)
结局指标
主要结局
Pharmacokinetics of simvastatin. AUC, Cmax and half life.
时间窗: days 1 and 14 of study
Pharmacokinetics of simvastatin acid. AUC, Cmax and half life.
时间窗: days 1 and 14 of study
Trough concentrations of PF-04531083 2, 4, 7, 11 and 14 days post commencement of dosing
时间窗: days 2, 4, 7, 11 and 14 of the study
次要结局
- safety and tolerability of PF-04531083 and simvastatin. Vital signs, laboratory tests and adverse events(days 1 and 15 of the study)
研究者
研究点 (1)
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