Bioequivalence Study of Gabapentin 400 mg Capsules Under Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00778271
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : October 23, 2008
Information provided by:
Ranbaxy Inc.

Brief Summary:
The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Parke-Davis (Neurontin®) 400 mg Gabapentin, following administration of a 400 mg dose under fasting conditions

Condition or disease Intervention/treatment Phase
Healthy Drug: Gabapentin 400mg capsules Not Applicable

Detailed Description:
This was an open-label, randomized, single-dose, 2-way crossover relative bioavailability study performed on 24 healthy adult volunteers and 2 alternates. A total of 26 subjects (22 males and 4 females) completed the clinical phase of the study. In each period, subjects were housed from at least 10 hours before dosing until after the 36-hour blood draw. Both periods were separated by a wash out period of 7 days A total of 26 healthy adult volunteers (22 males and 4 non-pregnant females) enrolled in and completed the clinical phase of the study enrolled in and completed the clinical phase of the study

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Ranbaxy and Park:-Davis (Neurontin®) 400 mg Gabapentin Capsules in Healthy Adult Volunteers Under Fasting Conditions
Study Start Date : September 2002
Actual Primary Completion Date : October 2002
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Gabapentin 400mg capsules
Drug: Gabapentin 400mg capsules
Active Comparator: 2
Neurontin® 400 mg capsules
Drug: Gabapentin 400mg capsules

Primary Outcome Measures :
  1. Bioequivalence

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy adult male or female volunteers, 18-55 years of age
  2. Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983)
  3. Medically healthy subjects with clinically normal laboratory profiles
  4. Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods:

    • surgically sterile (bilateral tubal ligation, hysterectomy bilateral oophorectomy) 6 months minimum;
    • IUD in place for at least 3 months;
    • barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the start of the study and throughout the study;
    • surgical sterilization of the partner (vasectomy for 6 months minimum); OR
    • hormonal contraceptives for at least 3 months prior to the start of the study.

    Other birth control methods may be deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years will be eligible.

  5. Voluntarily consent to participate in the study

Exclusion Criteria:

Subject candidates must not be enrolled in the study if they meet any of the following criteria:

  1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
  2. In addition, history or presence of:

    • alcoholism or drug abuse within the past 2 years; OR
    • hypersensitivity or idiosyncratic reaction to antibiotics, especially penicillins, cephalosporins and amoxicillin and/or clavulanic acid.
  3. Female subjects who are pregnant or lactating
  4. Subjects who have been on an abnormal diet (for whatever reason) during the 30 days prior to the first dose
  5. Subjects who, through completion of the study, would have donated in excess of:

    • 500 mL of blood in 14 days, or
    • 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
    • 1000 mL of blood in 90 days
    • 1250 mL of blood in 120 days
    • 1500 mL of blood in 180 days
    • 2000 mL of blood in 270 days
    • 2500 mL of blood in I year f) Subjects who have participated in another clinical trial within 28 days prior to the first dose

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00778271

Canada, Quebec
MDS Pharma Services
Saint-Laurent,, Quebec, Canada
Sponsors and Collaborators
Ranbaxy Laboratories Limited

Additional Information:
Responsible Party: Dr. tausif Monif, Ranbaxy Research labs Identifier: NCT00778271     History of Changes
Other Study ID Numbers: AA01819
First Posted: October 23, 2008    Key Record Dates
Last Update Posted: October 23, 2008
Last Verified: October 2008

Keywords provided by Ranbaxy Inc.:
Bioequivalence gabapentin 400mg capsules fasting conditions

Additional relevant MeSH terms:
gamma-Aminobutyric Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
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