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

Not Applicable

Completed

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

• Registration Number: NCT04108351
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-30
• Study Start: 2019-10-07
• Status Verified: 2020-02
• Primary Completion: 2020-02-11
• Study Completion: 2020-02-11
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Zopiclone	Harsh-braking test	-
Zopiclone	Road-tracking test	-
Placebo	Harsh-braking test	-
Placebo	Road-tracking test	-
Placebo	Car-following test	-
Zopiclone	Car-following test	-

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 (2)

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

The medical facility selected by Taisho Pharmaceutical Co., Ltd; 🇯🇵 Fukuoka, Japan