Healthy Participants
Conditions
Brief summary
The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control
Interventions
OTHERRoad-tracking test
Driving with simulator program for SDLP measurement
OTHERCar-following test
Intervention Description: Driving with simulator program for DCV measurement
OTHERHarsh-braking test
Driving with simulator program for BRT measurement
Sponsors
Nagoya University
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
21 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standard Deviation of Lateral Position (SDLP) | 60 min |
Secondary
| Measure | Time frame |
|---|---|
| Distance Coefficient of Variation (DCV) | 5 min |
| Brake Reaction Time (BRT) | 5 min |
Countries
Japan
Outcome results
None listed