Status:
COMPLETED
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
Lead Sponsor:
Taisho Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Nagoya University
Conditions:
Healthy Participants
Eligibility:
MALE
21-64 years
Phase:
NA
Brief Summary
The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04108351
Start Date
October 7 2019
End Date
February 11 2020
Last Update
February 28 2025
Active Locations (2)
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1
Taisho Pharmaceutical Co., Ltd selected site
Fukuoka, Japan
2
The medical facility selected by Taisho Pharmaceutical Co., Ltd
Fukuoka, Japan