Skip to main content
OpenTrials
Completed

NCT Number: NCT04108351

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Participants

Age range

21 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Taisho Pharmaceutical Co., Ltd selected site, Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Road-tracking test

Other

Driving with simulator program for SDLP measurement

Car-following test

Other

Intervention Description: Driving with simulator program for DCV measurement

Harsh-braking test

Other

Driving with simulator program for BRT measurement

Primary outcomes

  1. Standard Deviation of Lateral Position (SDLP)

    Time frame: 60 min

Secondary outcomes

  1. Distance Coefficient of Variation (DCV)

    Time frame: 5 min

  2. Brake Reaction Time (BRT)

    Time frame: 5 min

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Nagoya University

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 30, 2019
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.