NCT02303106已完成4 期
Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study.
Per Damkier1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Lamotrigine AUC
研究概览
简要总结
The investigators will study the effect of paracetamol on the steady state metabolism of lamotrigine in 12 healthy male volunteers.
Subjects will receive lamotrigine, slowly titrated from 25 mg daily to 100 mg daily over 28 days. On day 36, full plasma and urine PK samples will be drawn. On days 37-40 the subject will be co-administered 1 gr paracetamol 4 times daily. On day 40 the sampling will be repeated.
Primary outcome parameter is Lamotrigine AUC before and after coadministration of paracetamol.
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 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy no medication use
- •Informed consent
排除标准
- •Allergy to paracetamol or lamotrigine
研究组 & 干预措施
lamotrigine
Active Comparator
lamotrigine alone
干预措施: Lamotrigine (Drug)
Lamotrigine + paracetamol
Experimental
Lamotrigine + paracetamol
干预措施: Lamotrigine (Drug)
结局指标
主要结局
Lamotrigine AUC
时间窗: 24 hour
次要结局
未报告次要终点
研究者
Per Damkier
Head Consultant, MD, Ph.D.
Odense University Hospital
研究点 (1)
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