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

Overview[ - collapse ][ - ]

Purpose 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
ConditionHealthy
InterventionDrug: Gabapentin 400 mg capsules
Drug: NEURONTIN® 400 mg capsules
Drug: Gabapentin 400 mg capsules, single dose
PhasePhase 1
SponsorActavis Inc.
Responsible PartyActavis Inc.
ClinicalTrials.gov IdentifierNCT00864305
First ReceivedMarch 17, 2009
Last UpdatedAugust 13, 2010
Last verifiedAugust 2010

Tracking Information[ + expand ][ + ]

First Received DateMarch 17, 2009
Last Updated DateAugust 13, 2010
Start DateDecember 1997
Estimated Primary Completion DateJanuary 1998
Current Primary Outcome MeasuresRate and Extend of Absorption [Time Frame: 72 hours] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleA Relative Bioavailability Study of Gabapentin 400 mg Capsules Under Non-fasting Conditions
Official TitleA Relative Bioavailability Study of Gabapentin 400 mg Capsules Under Non-fasting Conditions
Brief 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
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 TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
ConditionHealthy
InterventionDrug: Gabapentin 400 mg capsules
A: Experimental Subjects received Purepac formulated products under fed conditions
Other Names:
GabapentinDrug: NEURONTIN® 400 mg capsules
B: Active comparator Subjects received Parke-Davis's marketed product
Other Names:
GabapentinDrug: Gabapentin 400 mg capsules, single dose
C: Experimental Subjects received Purepac formulated products under fasting conditions
Other Names:
Gabapentin
Study Arm (s)
  • Experimental: A
    Gabapentin 400 mg capsules
  • Active Comparator: B
    Neurontin 400 mg capsules

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment18
Estimated Completion DateJanuary 1998
Estimated Primary Completion DateJanuary 1998
Eligibility Criteria
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.
GenderMale
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00864305
Other Study ID NumbersB-09237
Has Data Monitoring CommitteeNo
Information Provided ByActavis Inc.
Study SponsorActavis Inc.
CollaboratorsNot Provided
Investigators Principal Investigator: Thomas Siler, M.D. Cetero Research, San Antonio
Verification DateAugust 2010

Locations[ + expand ][ + ]

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