NCT02147535已完成4 期
Impact of CES1 Genotype on Metabolism of Methylphenidate
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Plasma concentration of methylphenidate and ritalinic acid
研究概览
简要总结
The purpose of this study is to determine whether differences in the gene coding for the liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of methylphenidate, a CES1 dependent drug.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 18 years old
- •Caucasian
排除标准
- •Chronic disease (except hay fever and eczema)
- •Pregnancy
- •High level of alcohol consumption (> 21 units per week for men and 14 for women)
- •Known allergy towards methylphenidate
- •Permanent use of medication (contraception ok)
研究组 & 干预措施
Methylphenidate
Experimental
干预措施: Methylphenidate (Drug)
结局指标
主要结局
Plasma concentration of methylphenidate and ritalinic acid
时间窗: Predose and 3 hours post-dose
We are looking at the ratio of methylphenidate to ritalinic acid (metabolite) 3 hours post-dose as a measure of CES1 activity.
次要结局
- Metabolomic Profile(Predose/pre-meal, predose/post-meal and 3 hours post-dose)
研究者
研究点 (1)
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