Status:
COMPLETED
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Healthy
Eligibility:
All Genders
25-55 years
Phase:
PHASE3
Brief Summary
This study will examine the next-day residual effects of a nighttime dose of gabapentin 250 mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on simulated drivi...
Eligibility Criteria
Inclusion
- Healthy males and females of non-childbearing potential, 25-55 years of age
- Valid driver's license
Exclusion
- Psychiatric disorder
- Recent history of clinically significant neurological disorder, such as seizures, stroke, multiple sclerosis, or head trauma
- Recent histroy or current treatment for sleep disorder
Key Trial Info
Start Date :
July 29 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2013
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01888497
Start Date
July 29 2013
End Date
December 14 2013
Last Update
February 21 2021
Active Locations (4)
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1
Baptist Sleep Centers, LLP
South Miami, Florida, United States, 33143
2
Miami Research Associates
South Miami, Florida, United States, 33143
3
NeuroTrials Research Sleep Lab
Atlanta, Georgia, United States, 30342
4
NeuroTrials Research, Inc.
Atlanta, Georgia, United States, 30342