Bioequivalence Study of Gabapentin 400 mg Capsules Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00778765
First received: October 22, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

To compare the single-dose oral bioavailability of metformin HCI liquid 500 mg/5 mL of Ranbaxy with Glucophage® 1000 mg tablets of Bristol-Myers, USA following administration of a 1000 mg dose in healthy, adult, male and female volunteers under fasting conditions


Condition Intervention
Healthy
Drug: 400 mg Gabapentin Capsules

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Ranbaxy and Parke-Davis (Neurontin®) 400 mg Gabapentin Capsules in Healthy Adult Volunteers Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2002
Study Completion Date: December 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
400 mg Gabapentin Capsules of Ranbaxy
Drug: 400 mg Gabapentin Capsules
Active Comparator: 2
Neurontin® 400 mg Gabapentin Capsules
Drug: 400 mg Gabapentin Capsules

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. All 26 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 36-hour blood draw. Single oral 400 mg doses were separated by a washout period of 7 days A total of 24 healthy adult volunteers and 2 alternates (17 males and 9 non-pregnant females) enrolled in and completed the clinical phase of the study

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
    • 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
    • hypersensitivity or idiosyncratic reaction to anticonvulsants
  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 12 days
    • 1500 mL of blood in 180 days
    • 2000 mL of blood in 270 days
    • 2500 mL of blood in I year
  6. Subjects who have participated in another clinical trial within 28 days prior to the first dose
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778765

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

Additional Information:
No publications provided

Responsible Party: Dr. tausif Monif, Ranbaxy Research Labs
ClinicalTrials.gov Identifier: NCT00778765     History of Changes
Other Study ID Numbers: AA01820
Study First Received: October 22, 2008
Last Updated: October 22, 2008
Health Authority: Canada: Health Canada

Keywords provided by Ranbaxy Inc.:
Bioequivalence gabapentin fed conditions

Additional relevant MeSH terms:
Gabapentin
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

ClinicalTrials.gov processed this record on April 16, 2014