Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #1

Taisho Pharmaceutical

Status: Completed

Conditions: Healthy Participants

Treatments: Other: Harsh-braking test; Other: Car-following test; Other: Road-tracking test

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03278080

JapicCTI-173714 (Other Identifier)

DS-204-01

Details and patient eligibility

About

The purpose of this study is to set an optimal measurement time for assessing driving ability in a driving simulator in healthy volunteers.

Enrollment: 20 patients

Sex: Male

Ages: 21 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

driving test

Other group

Treatment:

Other: Car-following test

Other: Road-tracking test

Other: Harsh-braking test