A Relative Bioavailability Study of Gabapentin 400 mg Capsules Under Fasting Conditions

Study Overview
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Brief Summary
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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 fasting conditions

Detailed Description
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Study Type: Interventional Study Design: Single dose, randomized, two-period, two-treatment, two-sequence crossover study under fasting conditions comparing equal doses of the test and reference products. Official Title: A relative Bioavailability Study of Gabapentin 400 mg Capsules Under Fasting Conditions Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption

Official Title
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A Relative Bioavailability Study of Gabapentin 400 mg Capsules Under Fasting Conditions

Conditions
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Healthy

Intervention / Treatment
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* Drug: Gabapentin 400 mg capsules
* Drug: NEURONTIN® 400 mg capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Gabapentin 400 mg capsules | Drug: Gabapentin 400 mg capsules<br>* A: Experimental Subjects received Actavis formulated products under fasting conditions<br>* Other names: Gabapentin;|
| Active Comparator: B<br>Neurontin 400 mg capsules | Drug: NEURONTIN® 400 mg capsules<br>* B: Active comparator Subjects received Parke-Davis's marketed product<br>* Other names: Gabapentin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate and Extend of Absorption |  | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Gabapentin, Healthy subjects