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

PHASE4CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

April 30, 2005

Study Completion Date

May 31, 2005

Conditions
Insomnia
Interventions
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

Trial Locations (1)

33181

Pfizer Investigational Site, Miami

All Listed Sponsors
lead

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

NCT00666796 - A Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects | Biotech Hunter | Biotech Hunter