Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Peak plasma concentration (Cmax) of enalapril
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 two CES1 dependent drugs, enalapril and methylphenidate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older 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 and enalapril
- •Permanent use of medication (contraception ok)
研究组 & 干预措施
Methylphenidate
干预措施: Methylphenidate (Drug)
Enalapril
干预措施: Enalapril (Drug)
结局指标
主要结局
Peak plasma concentration (Cmax) of enalapril
时间窗: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
Peak plasma concentration (Cmax) of methylphenidate
时间窗: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Time to peak plasma concentration (Tmax) of methylphenidate
时间窗: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Terminal half life (t½) of methylphenidate
时间窗: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Area under the plasma concentration versus time curve (AUC) of methylphenidate
时间窗: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Time to peak plasma concentration (Tmax) of enalapril
时间窗: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
Terminal half life (t½) of enalapril
时间窗: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
Area under the plasma concentration versus time curve (AUC) of enalapril
时间窗: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
次要结局
- Metabolomic profile(Predose/pre-meal, predose/post-meal, 2 and 6 hours post-dose)
研究者
Gesche Jurgens
M.D., Ph.D.
Bispebjerg Hospital