NCT00966966已完成1 期
An Open-Label, Nonrandomized Study To Evaluate The Potential Pharmacokinetic Interaction Between SAM-531 and Gemfibrozil, A Cytochrome P-450 2C8 Inhibitor, When Coadministered Orally To Healthy Young Adult Subjects
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2009年9月最近更新:
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
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the effects of multiple doses of Gemfibrozil on the plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to assess the safety and tolerability of co-administration of SAM-531 and Gemfibrozil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg.
- •Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings.
排除标准
- •Presence or history of any disorder that may prevent the successful completion of the study.
- •Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
研究组 & 干预措施
1
Experimental
SAM-531_gemfibrozil
干预措施: SAM-531 and gemfibrozil (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax)
时间窗: 24 days
Time to maximum plasma concentration (tmax)
时间窗: 24 days
Area under the concentration-time curve (AUC)
时间窗: 24 days
次要结局
- Safety as measured by adverse event monitoring, ECG, vital signs, and laboratory tests(24 days)
研究者
研究点 (1)
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