MedTrace Logo

A Relative Bioavailability Study of Gabapentin 800 mg Tablets Under Fasting Conditions

NCT00864760 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

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 under fasting conditions.

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 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

More Related Trials

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 NCT00864760 on ClinicalTrials.gov