NCT04108351CompletedNot Applicable
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
Taisho Pharmaceutical Co., Ltd.2 sites in 1 country28 target enrollmentStarted: October 7, 2019Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Standard Deviation of Lateral Position (SDLP)
Study Overview
Brief Summary
The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 64 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
Zopiclone
Experimental
Intervention: Road-tracking test (Other)
Zopiclone
Experimental
Intervention: Car-following test (Other)
Zopiclone
Experimental
Intervention: Harsh-braking test (Other)
Placebo
Placebo Comparator
Intervention: Road-tracking test (Other)
Placebo
Placebo Comparator
Intervention: Car-following test (Other)
Placebo
Placebo Comparator
Intervention: Harsh-braking test (Other)
Outcomes
Primary Outcomes
Standard Deviation of Lateral Position (SDLP)
Time Frame: 60 min
Secondary Outcomes
- Brake Reaction Time (BRT)(5 min)
- Distance Coefficient of Variation (DCV)(5 min)
Investigators
Study Sites (2)
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