NCT00260247已完成4 期
Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Formation clearance of 3-hydroxyquinidine
研究概览
简要总结
This is a study of the possible effect of two antiepileptic drug on enzymes in the liver that metabolizes a number of drugs. It is a well know fact that carbamazepine induces some of these enzymes and this may reduce the effect of concomitantly administered drugs. Clinical observations suggest that oxcarbazepine does not induce these enzymes to the same degree.
This study directly compares the ability of these two drugs to induce the cytochrome P450 3A4 enzyme, in healthy volunteers using a well defined biomarker reaction of a specific enzyme activity.
It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI < 30
- •Non smoker
- •No signs or symptoms of disease by routine laboratory analysis, ECG and physical examination (general appearance assessment; pulmonal and cardiac stetoscopy; abdominal palpation)
- •Informed consent
排除标准
- •signs or symptoms of disease by routine laboratory analysis, ECG and physical examination
- •mental disease
- •participation in another clinical trial involving drugs with 3 months of randomization
- •donation of more than 500 mL blood within 3 months of randomization
- •intake of more than 21 alcohol equivanlents (one normal strength beer contain one alcohol equivalent)per week
结局指标
主要结局
Formation clearance of 3-hydroxyquinidine
次要结局
- Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine.
研究者
研究点 (2)
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