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A Relative Bioavailability Study of Gabapentin 400 mg Capsules Under Non-fasting Conditions

NCT00864305 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2010-08-17

No results posted yet for this study

Summary

To compare the relative bioavailability of gabapentin 400 mg capsules (Purepac) with that of NEURONTIN® 400 mg capsules (Parke-Davis) in healthy adult male subjects under non-fasting conditions, and to compare the differences in plasma levels after dosing the test formulation with and without food

Conditions

  • Healthy

Interventions

DRUG

Gabapentin 400 mg capsules

A: Experimental Subjects received Purepac formulated products under fed conditions

DRUG

NEURONTIN® 400 mg capsules

B: Active comparator Subjects received Parke-Davis's marketed product

DRUG

Gabapentin 400 mg capsules, single dose

C: Experimental Subjects received Purepac formulated products under fasting conditions

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Siler, M.D. · Cetero Research, San Antonio

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
1997-12-31
Primary Completion
1998-01-31
Completion
1998-01-31

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 NCT00864305 on ClinicalTrials.gov