跳至主要内容
临床试验/NCT03278080
NCT03278080已完成不适用

Development of Assessment Method of Driving Ability Using Driving Simulator in Healthy Volunteers #1: Measurement Setup of Assessment Criteria for Driving Ability

Taisho Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年9月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
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 set an optimal measurement time for assessing driving ability in a driving simulator in healthy volunteers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
21 Years 至 64 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Body mass index (BMI) ≥18.5 and <25.0 kg/m2 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

排除标准

  • History of drug and food allergy
  • Routinely drink alcohol before bedtime
  • Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator

结局指标

主要结局

Standard Deviation of Lateral Position (SDLP)

时间窗: 60 min.

次要结局

  • Distance Coefficient of Variation (DCV)(25 min.)
  • Brake Reaction Time (BRT)(15 min.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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