跳至主要内容
临床试验/NCT00798395
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.

Merck Sharp & Dohme LLC0 个研究点目标入组 32 人开始时间: 2007年10月最近更新:
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

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

申办方类型
Industry
责任方
Sponsor

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