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Bioequivalence Study of Gabapentin 800 mg Tablets Under Fasting Conditions

NCT00778401 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2008-10-23

No results posted yet for this study

Summary

This study compared the relative bioavailability (rate and extent of absorption) of the test Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited to the reference Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd., distributed by Parke Davis, division of Warner-Lambert Co. in 28 healthy, adult subjects (21 males and 7 females) under fasting conditions using randomized, two-way crossover design.

Conditions

  • Healthy

Interventions

DRUG

Gabapentin tablets 800 mg

Sponsors & Collaborators

  • Ranbaxy Laboratories Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2002-10-31
Completion
2002-12-31

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 NCT00778401 on ClinicalTrials.gov