A Limited Food Effect Study of Gabapentin 800 mg Tablets

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00865631
First received: March 17, 2009
Last updated: August 13, 2010
Last verified: August 2010
  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.


Condition Intervention Phase
Healthy
Drug: Gabapentin 800 mg tablets, single dose (1 tablet)
Drug: NEURONTIN® 400 mg capsules, single dose (2 capsules)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Limited Food Effect Study of 800 mg Gabapentin Tablets Versus 400 mg Gabapentin Capsules

Resource links provided by NLM:


Further study details as provided by Actavis Inc.:

Primary Outcome Measures:
  • Rate and Extend of Absorption [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: June 1999
Study Completion Date: June 1999
Primary Completion Date: June 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Gabapentin 800 mg tablets, single dose (1 tablet)
Drug: Gabapentin 800 mg tablets, single dose (1 tablet)
A: Experimental Subjects received Purepac formulated products under fasting conditions
Other Name: Gabapentin
Drug: Gabapentin 800 mg tablets, single dose (1 tablet)
A: Experimental Subjects received Purepac formulated products under non-fasting conditions
Other Name: Gabapentin
Active Comparator: B
NEURONTIN® 400 mg capsules, single dose (2 capsules)
Drug: NEURONTIN® 400 mg capsules, single dose (2 capsules)
B: Active comparator Subjects received Parke-Davis formulated products under non-fasting conditions
Other Name: Gabapentin

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865631

Locations
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58102
Sponsors and Collaborators
Actavis Inc.
Investigators
Principal Investigator: James D. Carlson,, Pharm. D. PRACS Institute, Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier: NCT00865631     History of Changes
Other Study ID Numbers: P99-229
Study First Received: March 17, 2009
Last Updated: August 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Actavis Inc.:
Bioequivalence
Gabapentin
Healthy subjects

Additional relevant MeSH terms:
Gabapentin
Gamma-Aminobutyric Acid
Analgesics
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antimanic Agents
Antiparkinson Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
GABA Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014