NCT00692263已完成4 期
The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects
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
- 15
- 试验地点
- 1
- 主要终点
- AUC of (+)-M1 metabolite of tramadol
研究概览
简要总结
Escitalopram will be given to a panel of 16 healthy subject for 9 days. On the ninth day a single dose of tramadol is administered to the subjects and pharmacokinetic(PK) and pharmacodynamic(PD) measurements are done for the next 24 hours.
It is stated that escitalopram is only a weak inhibitor of CYP2D6 and therefore no effect is seen in Pk or PK of tramadol
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
- Triple (Participant, Care Provider, Investigator)
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
- •Age: 18 - 45 years
- •CYP2D6 phenotyped as extensive metabolizer
- •CYP2C19 phenotyped as extensive metabolizer
排除标准
- •Alcohol or drug abuse
研究组 & 干预措施
A
Experimental
Escitalopram - tramadol
干预措施: escitalopram and tramadol (Drug)
B
Experimental
Placebo - tramadol
干预措施: placebo and tramadol (Drug)
C
Experimental
placebo - placebo
干预措施: placebo (Drug)
结局指标
主要结局
AUC of (+)-M1 metabolite of tramadol
时间窗: 24 hours
次要结局
- Dynamic pupillometry(24 hours)
研究者
研究点 (1)
Loading locations...
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