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

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00864305
First received: March 17, 2009
Last updated: August 13, 2010
Last verified: August 2010
  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


Condition Intervention Phase
Healthy
Drug: Gabapentin 400 mg capsules
Drug: NEURONTIN® 400 mg capsules
Drug: Gabapentin 400 mg capsules, single dose
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of Gabapentin 400 mg Capsules Under Non-fasting Conditions

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: December 1997
Study Completion Date: January 1998
Primary Completion Date: January 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Gabapentin 400 mg capsules
Drug: Gabapentin 400 mg capsules
A: Experimental Subjects received Purepac formulated products under fed conditions
Other Name: Gabapentin
Drug: Gabapentin 400 mg capsules, single dose
C: Experimental Subjects received Purepac formulated products under fasting conditions
Other Name: Gabapentin
Active Comparator: B
Neurontin 400 mg capsules
Drug: NEURONTIN® 400 mg capsules
B: Active comparator Subjects received Parke-Davis's marketed product
Other Name: Gabapentin

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  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: NCT00864305

Locations
United States, Missouri
Gateway Medical Research, Inc
St. Charles, Missouri, United States, 63301
Sponsors and Collaborators
Actavis Inc.
Investigators
Principal Investigator: Thomas Siler, M.D. Cetero Research, San Antonio
  More Information

No publications provided

Responsible Party: Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier: NCT00864305     History of Changes
Other Study ID Numbers: B-09237
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
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents

ClinicalTrials.gov processed this record on August 18, 2014