Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers

• Status: Completed
• Trial end date: 2013-12-14
• Target enrollment: 0
• Participant gender: All

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 driving performance in normal volunteer subjects. It will also examine other measures of next-day performance and next-day sleepiness.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Diphenhydramine; Gabapentin; gamma-Aminobutyric Acid; Promethazine; Triazolam

Criteria

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