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NCT04108351 Clinical Trial

Development and Validation of a Driving Simulator for Evaluating the Residual Effects of Drugs on Driving Performance - Sensitivity Analysis Using Zopiclone as a Positive Control

Healthy Participants Clinical Trial

Official title:
Development and Validation of a Driving Simulator for Evaluating the Residual Effects of Drugs on Driving Performance - Sensitivity Analysis Using Zopiclone as a Positive Control

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04108351
Other study ID # DS-204-04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 7, 2019
Est. completion date February 11, 2020

Study information
Verified date February 2020
Source Taisho Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date February 11, 2020
Est. primary completion date February 11, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 21 Years to 64 Years
Eligibility 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 - Other protocol defined inclusion criteria could apply Exclusion Criteria: - History of drug and food allergy - Hypersensitivity to zopiclone - Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator - Other protocol defined inclusion criteria could apply

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Road-tracking test
Driving with simulator program for SDLP measurement
• Car-following test
Intervention Description: Driving with simulator program for DCV measurement
• Harsh-braking test
Driving with simulator program for BRT measurement

Locations
Country Name City State
Japan Taisho Pharmaceutical Co., Ltd selected site Fukuoka
Japan The medical facility selected by Taisho Pharmaceutical Co., Ltd Fukuoka

Sponsors (2)
Lead Sponsor Collaborator
Taisho Pharmaceutical Co., Ltd. Nagoya University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Standard Deviation of Lateral Position (SDLP) 60 min
Secondary Distance Coefficient of Variation (DCV) 5 min
Secondary Brake Reaction Time (BRT) 5 min
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