NCT00666796

A Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects

A Randomized, Double-Blind, 4-way Crossover, Placebo-Controlled, Single Center Trial to Evaluate the Potential Pharmacodynamic Interaction Between Gabapentin 500 mg and Ethanol in Healthy Volunteers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the pharmacodynamic interaction between gabapentin and ethanol

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	Placebo ethanol	Matched placebo ethanol 0.4% in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint
DRUG	Ethanol	Ethanol 0.7 g/kg in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint
DRUG	Placebo	Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint
DRUG	Gabapentin	Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
DRUG	Ethanol	Ethanol 0.7 g/kg in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint
DRUG	Placebo	Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint
DRUG	Gabapentin	Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
DRUG	Placebo ethanol	Matched placebo ethanol 0.4% in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint

Timeline

• Start date: 2005-04-01
• Completion: 2005-05-01
• First posted: 2008-04-25
• Last updated: 2021-02-02

Locations

1 site across 1 country: United States