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
Status
Completed
Conditions
Healthy Participants
Treatments
Other: Car-following test
Other: Harsh-braking test
Other: Road-tracking test
Details and patient eligibility
About
The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control
Enrollment
28 patients
Sex
Male
Ages
21 to 64 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Quadruple Blind
28 participants in 2 patient groups, including a placebo group
Zopiclone
Experimental group
Treatment:
Other: Road-tracking test
Other: Harsh-braking test
Other: Car-following test
Placebo
Placebo Comparator group
Treatment:
Other: Road-tracking test
Other: Harsh-braking test
Other: Car-following test
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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