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A Limited Food Effect Study of Gabapentin 800 mg Tablets

NCT00865631 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2010-08-17

No results posted yet for this study

Summary

The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin Tablets by Purepac Pharmaceutical Co. with that of 400 mg (2 x 400 mg) NEURONTIN® by Parke-Davis following a single oral dose (1 x 800 mg tablet) or (2 x 400 mg capsules) in healthy adult male volunteers under non-fasting conditions, and will compare the differences in plasma levels after dosing the test formulation with and without food.

Conditions

  • Healthy

Interventions

DRUG

Gabapentin 800 mg tablets, single dose (1 tablet)

A: Experimental Subjects received Purepac formulated products under fasting conditions

DRUG

NEURONTIN® 400 mg capsules, single dose (2 capsules)

B: Active comparator Subjects received Parke-Davis formulated products under non-fasting conditions

DRUG

Gabapentin 800 mg tablets, single dose (1 tablet)

A: Experimental Subjects received Purepac formulated products under non-fasting conditions

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • James D. Carlson,, Pharm. D. · PRACS Institute, Ltd.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-06-30
Primary Completion
1999-06-30
Completion
1999-06-30

Countries

  • United States

Study Locations

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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 NCT00865631 on ClinicalTrials.gov