Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 25 - 55 |
| Updated: | 11/30/2013 |
| Start Date: | July 2013 |
| End Date: | December 2013 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
A Phase 3 Randomized, Double-blind, Cross-over, Placebo-controlled, Multi-center, Single-dose, Clinical Trial to Assess the Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
This study will examine the next-day residual effects of a nighttime dose of gabapentin 250
mg, diphenhydramine citrate 76 mg and triazolam 50 mg compared to placebo and each other on
simulated driving performance in normal volunteer subjects. It will also examine other
measures of next-day performance and next-day sleepiness.
Inclusion Criteria:
- Healthy males and females of non-childbearing potential, 25-55 years of age
- Valid driver's license
Exclusion Criteria:
- 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
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Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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