NCT04108351已完成不适用
Development and Validation of a Driving Simulator for Evaluating the Residual Effects of Drugs on Driving Performance - Sensitivity Analysis Using Zopiclone As a Positive Control
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Standard Deviation of Lateral Position (SDLP)
研究概览
简要总结
The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥18.5 and <25.0 kg/m^2 at screening inspection
- •No visual impairment (enable to correct the vision with eyeglasses or contact lens)
- •Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study
- •Other protocol defined inclusion criteria could apply
排除标准
- •History of drug and food allergy
- •Hypersensitivity to zopiclone
- •Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator
- •Other protocol defined inclusion criteria could apply
结局指标
主要结局
Standard Deviation of Lateral Position (SDLP)
时间窗: 60 min
次要结局
- Brake Reaction Time (BRT)(5 min)
- Distance Coefficient of Variation (DCV)(5 min)
研究者
研究点 (2)
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