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

NCT00666796 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-02-02

No results posted yet for this study

Summary

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

Conditions

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

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-04-30
Completion
2005-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00666796 on ClinicalTrials.gov