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Bioequivalence Study of Gabapentin 800 mg Tablets Under Fasting Conditions
This study has been completed.
Sponsored by: Ranbaxy Laboratories Limited
Information provided by: Ranbaxy Inc.
ClinicalTrials.gov Identifier: NCT00778401
  Purpose

This study compared the relative bioavailability (rate and extent of absorption) of the test Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited to the reference Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd., distributed by Parke Davis, division of Warner-Lambert Co. in 28 healthy, adult subjects (21 males and 7 females) under fasting conditions using randomized, two-way crossover design.


Condition Intervention
Healthy
Drug: Gabapentin tablets 800 mg

Drug Information available for: Gabapentin
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Official Title: A Relative Bioavailability Study of 800 mg Gabapentin Tablets Under Fasting Condition

Further study details as provided by Ranbaxy Inc.:

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

Enrollment: 28
Study Start Date: October 2002
Study Completion Date: December 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited
Drug: Gabapentin tablets 800 mg
2: Active Comparator
Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd.
Drug: Gabapentin tablets 800 mg

Detailed Description:

A single oral dose of the test or reference product was administered to the volunteers on two separate occasions under fasting conditions with at least a 7 day washout between doses. Food and fluid intake were controlled during each confinement period.

A total of twenty eight (28) healthy subjects (21 males and 7 females) were enrolled in the study of which twenty seven (27) subjects completed the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. All volunteers selected for this study will be healthy men or women 18 years of age or older at the time of dosing.
  2. The weight range will not exceed ± 20 % for height and body frame as per desirable weights for adult - 1983 Metropolitan Height and Weight Table
  3. If female and:

Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator (s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or Is postmenopausal for at least 1 year; or Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

Exclusion Criteria:

  1. Volunteers with a recent history of drug or alcohol addiction or abuse
  2. Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system (s) or psychiatric disease (as determined by the clinical investigators)
  3. Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant
  4. Volunteers demonstrated a positive hepatitis B surface antigen screen or a reactive HIV antibody screen
  5. Volunteers demonstrating a positive drug abuse screen when screened for this study
  6. Female volunteers demonstrating a positive pregnancy screen
  7. Female volunteers who are currently breast feeding
  8. Volunteers with history of allergic response(s) to Gabapentin or related drugs
  9. Volunteers with a history of clinically significant allergies including drug allergies
  10. Volunteers with a history of clinically significant illness during the 4 weeks prior to period I dosing (as determined by the clinical investigators)
  11. Volunteers who currently use tobacco products
  12. Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to period I dosing
  13. Volunteers who report donating greater than 150 mL of the blood within 30 days prior to period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study
  14. Volunteers who have donated plasma (eg. Plasmapheresis) within 14 days prior to period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study
  15. Volunteers who report receiving any investigational drug within 30 days prior to period I dosing
  16. Volunteers who report taking any systemic prescription medication in the 14 days prior to period I dosing.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778401

Locations
United States, North Dakota
PRACS Institute Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Ranbaxy Research Labs ( Dr. Tausif Monif )
Study ID Numbers: R01-825
Study First Received: October 22, 2008
Last Updated: October 22, 2008
ClinicalTrials.gov Identifier: NCT00778401  
Health Authority: United States: Institutional Review Board

Keywords provided by Ranbaxy Inc.:
Bioequivalence Gabapentin tablets 800 mg fasting conditions

Study placed in the following topic categories:
Excitatory Amino Acids
Calcium, Dietary
Gabapentin
Healthy

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Membrane Transport Modulators
Sensory System Agents
Therapeutic Uses
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 14, 2009