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Completed

NCT Number: NCT03572985

Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #3

The purpose of this study is to collect alcohol calibration data for the driving simulator.

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Key information

Conditions

Healthy Participants

Age range

21 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Taisho Pharmaceutical Co., Ltd selected site

Fukuoka, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • History of drug and food allergy
  • Alcohol dependence, drug dependence or abnormal drunken (including past history)
  • Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator

Treatment and study plan

Road-tracking test

Other

Driving with simulator program for SDLP measurement

Car-following test

Other

Driving with simulator program for DCV measurement

Harsh-braking test

Other

Driving with simulator program for BRT measurement

Primary outcomes

  1. Standard Deviation of Lateral Position (SDLP)

    Time frame: 60 min

Secondary outcomes

  1. Distance Coefficient of Variation (DCV)

    Time frame: 5 min

  2. Brake Reaction Time (BRT)

    Time frame: 5 min

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Nagoya University

Registry information

Official study title

Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #3: Alcohol Calibration

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2018
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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