Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #2

Not Applicable

Completed

• Conditions: Healthy Participants

• Registration Number: NCT03413592
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to verify the intra-individual difference of the SDLP values in driving simulator.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-16
• Study Start: 2018-01-22
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-29
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2018-07
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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