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

August 13, 2010 updated by: Actavis Inc.
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Type: Interventional Study Design: Single dose, randomized, three-period, three-treatment, six-sequence crossover study under non-fasting conditions (test and reference) and fasting (test) conditions

Official Title: A relative Bioavailability Food Challenge Study of Gabapentin 400 mg Capsules

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • Gateway Medical Research, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • All subjects selected for this study will be males 18 to 45 (inclusive) years of age. Weight range of the subjects shall be 135-246 pounds, with individual weight variation not more than 10% ± from normal for height and body frame (Metropolitan Life, 1983, Height, Weight, Body Chart).
  • Each subject shall be given a general physical examination within 21 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history.

At the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements.

Adequate blood and urine samples should be obtained within 21 days before beginning of the first period and at the end of the trial for clinical laboratory measurements. Clinical laboratory measurements will include the following:

Hematology: hemoglobin, hematocrit, red blood cell count, platelets, and white blood cell count (with differential).

Clinical Chemistry: creatinine, BUN, glucose, SGOT, SGPT, bilirubin, and alkaline phosphate Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, and cells.

HTLV III Screen: (pre-study only) Hepatitis-B Surface Ag Screen: (pre-study only) Drugs of Abuse Screen: (pre-study only) Subjects will be selected if all above are normal.

Exclusion Criteria:

  • Subjects with a history of chronic alcohol consumption, drug addition, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
  • Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be restricted. If the clinical values are outside the range on testing, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
  • Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study.
  • Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
  • All subjects will have urine samples assayed for the presence of drugs of abuse as a part of the clinical laboratory screening procedures. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
  • Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to starting the study.
  • Subjects who have taken any investigational drug within thirty (30) days prior to the start of the study will not be allowed to participate.
  • Subjects who have been exposed to known hepatic enzyme inducting or inhibiting agents within thirty (30) days prior to dosing will not be allowed to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Gabapentin 400 mg capsules
Drug: Gabapentin 400 mg capsules
A: Experimental Subjects received Purepac formulated products under fed conditions
Other Names:
  • Gabapentin
Drug: Gabapentin 400 mg capsules, single dose
C: Experimental Subjects received Purepac formulated products under fasting conditions
Other Names:
  • Gabapentin
Active Comparator: B
Neurontin 400 mg capsules
Drug: NEURONTIN® 400 mg capsules
B: Active comparator Subjects received Parke-Davis's marketed product
Other Names:
  • Gabapentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate and Extend of Absorption
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actavis Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1997

Primary Completion (Actual)

January 1, 1998

Study Completion (Actual)

January 1, 1998

Study Registration Dates

First Submitted

March 17, 2009

First Submitted That Met QC Criteria

March 17, 2009

First Posted (Estimate)

March 18, 2009

Study Record Updates

Last Update Posted (Estimate)

August 17, 2010

Last Update Submitted That Met QC Criteria

August 13, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-09237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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