NCT00566865已完成1 期
A Double-Blind, Placebo-Controlled Study to Assess the Effect of Gemfibrozil Co-Administration on the Pharmacokinetics and Pharmacodynamics of Mitiglinide in Healthy Volunteers
Elixir Pharmaceuticals0 个研究点目标入组 14 人开始时间: 2007年11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
- 14
- 主要终点
- pharmacokinetics of mitiglinide
研究概览
简要总结
The primary objective of this study is to determine the extent of effect of gemfibrozil on the pharmacokinetics and pharmacodynamics of mitiglinide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •non-smoker
- •Body mass index (BMI) of 19-28 kg/m2
- •no relevant food allergies
排除标准
- •any subject for whom gemfibrozil is contraindicated
- •any subject with a history of hypoglycemia or who tend to get easily hypoglycemic
- •clinically significant history of or current abnormality or disease of any organ system
研究组 & 干预措施
2
Experimental
mitiglinide + gemfibrozil
干预措施: gemfibrozil (Drug)
1
Placebo Comparator
mitiglinide + placebo for gemfibrozil
干预措施: placebo for gemfibrozil (Drug)
结局指标
主要结局
pharmacokinetics of mitiglinide
时间窗: 3 days of treatment with gemfibrozil
pharmacodynamics of mitiglinide
时间窗: 3 days of treatment with gemfibrozil
次要结局
- safety and tolerance of mitiglinide when co-administered with 600 mg gemfibrozil(3 days of treatment with gemfibrozil)
研究者
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