A Limited Food Effect Study of Gabapentin 800 mg Tablets

Overview[ - collapse ][ - ]

Purpose 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 following a single oral dose (1 x 800 mg tablet) or (2 x 400 mg capsules) in healthy adult male volunteers under non-fasting conditions, and will compare the differences in plasma levels after dosing the test formulation with and without food.
ConditionHealthy
InterventionDrug: Gabapentin 800 mg tablets, single dose (1 tablet)
Drug: NEURONTIN® 400 mg capsules, single dose (2 capsules)
Drug: Gabapentin 800 mg tablets, single dose (1 tablet)
PhasePhase 1
SponsorActavis Inc.
Responsible PartyActavis Inc.
ClinicalTrials.gov IdentifierNCT00865631
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 DateJune 1999
Estimated Primary Completion DateJune 1999
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 Limited Food Effect Study of Gabapentin 800 mg Tablets
Official TitleA Limited Food Effect Study of 800 mg Gabapentin Tablets Versus 400 mg Gabapentin Capsules
Brief 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 following a single oral dose (1 x 800 mg tablet) or (2 x 400 mg capsules) in
healthy adult male volunteers under non-fasting conditions, and will compare the differences
in plasma levels after dosing the test formulation with and without food.
Detailed Description
Study Type: Interventional Study Design: Randomized, single-dose, three-way crossover
under fed and fasting conditions

Official Title: A Limited Food Effect Study of 800 mg Gabapentin Tablets versus 400 mg
Gabapentin 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 800 mg tablets, single dose (1 tablet)
A: Experimental Subjects received Purepac formulated products under fasting conditions
Other Names:
GabapentinDrug: NEURONTIN® 400 mg capsules, single dose (2 capsules)
B: Active comparator Subjects received Parke-Davis formulated products under non-fasting conditions
Other Names:
GabapentinDrug: Gabapentin 800 mg tablets, single dose (1 tablet)
A: Experimental Subjects received Purepac formulated products under non-fasting conditions
Other Names:
Gabapentin
Study Arm (s)
  • Experimental: A
    Gabapentin 800 mg tablets, single dose (1 tablet)
  • Active Comparator: B
    NEURONTIN® 400 mg capsules, single dose (2 capsules)

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment18
Estimated Completion DateJune 1999
Estimated Primary Completion DateJune 1999
Eligibility Criteria
Inclusion Criteria:

- Screening Demographics: All volunteers selected for this study will be healthy men 18
to 45 years of age, inclusive, at the time of dosing. The weight range will not
exceed ± 15% for height and body frame as per Desirable Weights for Men• 1983
Metropolitan Height and Weight Table.

- Screening Procedures: Each volunteer will complete the screening process within 28
days prior to Period I dosing. Consent documents for both the screening evaluation
and HIV antibody determination will be reviewed, discussed, and signed by each
potential participant before full implementation of screening procedures.

- Screening will include general observations, physical examination, demographics,
medical and medication history, an electrocardiogram, sitting blood pressure and
heart rate, respiratory rate and temperature. The physical examination will include,
but may not be limited to, an evaluation of the cardiovascular, gastrointestinal,
respiratory and central nervous systems.

- The screening clinical laboratory procedures will include:

- HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count,
platelet count;

- CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin,
total bilirubin, total protein, and alkaline phosphatase;

- HIV antibody and hepatitis B surface antigen screens;

- URINALYSIS: pH, albumin, sugar, acetone, bilirubin, occult blood and microscopic
analysis; and

- URINE DRUG SCREEN: ethyl alcohol. amphetamines. barbiturates, benzodiazepines,
cannabinoids. cocaine metabolites, opiates and phencyclidine.

Exclusion Criteria:

- Volunteers with a recent history of drug or alcohol addiction or abuse.

- Volunteers with the presence ofa clinically significant disorder involving the
cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic,
endocrine, or neurologic system(s) or psychiatric disease (as determined by the
medical investigator).

- Volunteers whose clinical laboratory test values are outside the accepted reference
range and when confirmed on re-examination are deemed to be clinically significant.

- Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive
HIV antibody screen.

- Volunteers demonstrating a positive drug abuse screen when screened for this study.

- Volunteers with a history of allergic response(s) to gabapentin or related drugs.

- Volunteers with a history of clinically significant allergies including drug
allergies.

- Volunteers with a clinically significant illness during the 4 weeks prior to Period I
dosing (as determined by the medical investigator.

- Volunteers who currently use tobacco products.

- Volunteers who have taken any drug known to induce or inhibit hepatic drug -
Volunteers who report donating greater than 150 mL of blood within 30 days prior to
Period I dosing. All subjects will be advised not to donate blood for four weeks
after completing the study.

- Volunteers who have donated plasma (e.g. plasmaphoresis) within 14 days prior to
Period I dosing. All subjects will be advised not to donate plasma for four weeks
after completing the study.

- Volunteers who report receiving any investigational drug within 30 days prior to
Period I dosing.

- Volunteers who report taking any systemic prescription medication in the 14 days
prior to Period I dosing.
GenderMale
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00865631
Other Study ID NumbersP99-229
Has Data Monitoring CommitteeNo
Information Provided ByActavis Inc.
Study SponsorActavis Inc.
CollaboratorsNot Provided
Investigators Principal Investigator: James D. Carlson,, Pharm. D. PRACS Institute, Ltd.
Verification DateAugust 2010

Locations[ + expand ][ + ]

PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58102