Bioequivalence Study of Gabapentin 800 mg Tablets Under Fasting Conditions

Official Title: “A Relative Bioavailability Study of 800 mg Gabapentin Tablets Under Fasting Condition”

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.

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.

Intervention(s) in this Clinical Trial

• Drug: Gabapentin tablets 800 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited
• Active Comparator: 2
  • Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd.

Primary Measures

• Bioequivalence
  • Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Ranbaxy Laboratories Limited Industry

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00778401

Study ID Number: R01-825

ClinicalTrials.gov Identifier: NCT00778401

Health Authority: United States: Institutional Review Board