NCT00798395已完成1 期
A Randomized Double-blind, Placebo-controlled, 4-period Cross-over Study to Assess the Effect of Single and Multiple Doses of 1.5 mg and 4.5 mg Org 50081 and a Single Dose of 7.5 mg Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- The Standard Deviation of Lateral Position
研究概览
简要总结
This trial is to investigate the effect on next-day driving performance and psychomotor performance in healthy volunteers.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has at least 3 years of car driving experience
- •Subject signs the trial Informed Consent Form
- •Subject is in a healthy condition as judged by the investigator
- •Subject has a regular sleep pattern
排除标准
- •Subject has insomnia or any other sleep disorder
- •Medication or drug use of any kind prior to the study
- •Relevant history or presence of a significant medical illness
研究组 & 干预措施
Treatment 1
Experimental
干预措施: Org 50081 (Drug)
Treatment 2
Experimental
干预措施: Org 50081 (Drug)
Treatment 3
Placebo Comparator
干预措施: Placebo (Drug)
Treatment 4
Active Comparator
干预措施: zopiclone (Drug)
结局指标
主要结局
The Standard Deviation of Lateral Position
时间窗: Day 8
次要结局
- Psychomotor and cognitive performance tasks(Day 8)
研究者
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