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Bioequivalence Study of Gabapentin 800 mg Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00778232
First received: October 22, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted

October 22, 2008
October 22, 2008
October 2002
November 2002   (final data collection date for primary outcome measure)
Bioequivalence [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioequivalence Study of Gabapentin 800 mg Tablets Under Fed Conditions
A Relative Bioavailability Study of 800 mg Gabapentin Tablets Under Non-Fasting Conditions

This study compared the relative bioavailability (rate and extent of absorption) of Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited with that of Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd. Distributed by Parke-Davis, division of Warner-Lambert Co. following a single oral dose (1x800 mg tablet) in healthy adult volunteers under non-fasting conditions.

A single oral dose of the test or the reference product was administered to 22 healthy adult human volunteers on two separate occasions under non-fasting conditions with at least a 7 day washout between the doses. Food and the fluid intake were controlled during each confinement period.

Twenty two (22) healthy adult human volunteers (12 males and 10 females) were enrolled in the study. All twenty two (22) subjects successfully completed the clinical portion of the study

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
Drug: Gabapentin tablets 800 mg
  • Experimental: 1
    Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited
    Intervention: Drug: Gabapentin tablets 800 mg
  • Active Comparator: 2
    Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd
    Intervention: Drug: Gabapentin tablets 800 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
November 2002
November 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. All volunteers selected for the study will be healthy men or women 18 years of age or older at the time of dosing
  2. The weight will no exceed ± 20% for the height and body frame as per desirable weight for adults - 1983 Metropolitan height and weight table
  3. If female and Of Child bearing 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 devices (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 demonstrating 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 a 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 clinically significant illness during the 4 weeks prior to period I dosing (as determined by the clinical investigators)
  11. Volunteers who are currently using 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 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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00778232
R01-826
Yes
Dr. Tausif Monif, Ranbaxy Research Labs
Ranbaxy Laboratories Limited
Not Provided
Not Provided
Ranbaxy Inc.
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP