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

NCT00864305 | Completed Phase 1

• 1 other identifier: B-09237
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

Bioequivalence; Gabapentin; Healthy subjects

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  72 hours

Study Arms (2)

A

EXPERIMENTAL

Gabapentin 400 mg capsules

Drug: Gabapentin 400 mg capsules; Drug: Gabapentin 400 mg capsules, single dose

B

ACTIVE COMPARATOR

Neurontin 400 mg capsules

Drug: NEURONTIN® 400 mg capsules

Interventions

Gabapentin 400 mg capsules DRUG

A: Experimental Subjects received Purepac formulated products under fed conditions

Also known as: Gabapentin

A

NEURONTIN® 400 mg capsules DRUG

B: Active comparator Subjects received Parke-Davis's marketed product

Also known as: Gabapentin

B

Gabapentin 400 mg capsules, single dose DRUG

C: Experimental Subjects received Purepac formulated products under fasting conditions

Also known as: Gabapentin

A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

Gateway Medical Research, Inc

Saint Charles, Missouri, 63301, United States

Location

MeSH Terms

Interventions

Gabapentin

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Thomas Siler, M.D.

  Cetero Research, San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: December 1, 1997
• Primary Completion: January 1, 1998
• Study Completion: January 1, 1998
• Last Updated: August 17, 2010

Record last verified: 2010-08

Locations

US (1)