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

Not Applicable

Completed

• Conditions: Healthy Participants
• Interventions: Other: Road-tracking test; Other: Car-following test; Other: Harsh-braking test

• Registration Number: NCT03572985
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-06-19
• Study Start: 2018-06-27
• Study First Posted: 2018-06-28
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-11
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BAC level 0.05 %	Car-following test	Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.05%
BAC level 0 %	Road-tracking test	Drink beverages containing non alcohol
BAC level 0 %	Car-following test	Drink beverages containing non alcohol
Blood alcohol concentration (BAC) level 0.025 %	Car-following test	Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.025%
BAC level 0.05 %	Harsh-braking test	Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.05%
BAC level 0.09 %	Harsh-braking test	Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.09%
BAC level 0.09 %	Car-following test	Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.09%
BAC level 0 %	Harsh-braking test	Drink beverages containing non alcohol
Blood alcohol concentration (BAC) level 0.025 %	Road-tracking test	Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.025%
Blood alcohol concentration (BAC) level 0.025 %	Harsh-braking test	Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.025%
BAC level 0.05 %	Road-tracking test	Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.05%
BAC level 0.09 %	Road-tracking test	Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.09%

Primary Outcome Measures

Name	Time	Method
Standard Deviation of Lateral Position (SDLP)	60 min

Secondary Outcome Measures

Name	Time	Method
Brake Reaction Time (BRT)	5 min
Distance Coefficient of Variation (DCV)	5 min

Trial Locations

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site; 🇯🇵 Fukuoka, Japan