Expired Study
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Fargo, North Dakota 58104


Purpose:

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.


Study summary:

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


Criteria:

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.


Study is Available At:


Original ID:

R01-826


NCT ID:

NCT00778232


Secondary ID:


Study Acronym:


Brief Title:

Bioequivalence Study of Gabapentin 800 mg Tablets Under Fed Conditions


Official Title:

A Relative Bioavailability Study of 800 mg Gabapentin Tablets Under Non-Fasting Conditions


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ranbaxy Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

22


Enrollment Type:

Actual


Study Dates

Start Date:October 2002
Completion Date:November 2002
Completion Type:Actual
Primary Completion Date:November 2002
Primary Completion Type:Actual
Verification Date:October 2008
Last Changed Date:October 22, 2008
First Received Date:October 22, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Bioequivalence
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Gabapentin tablets 800 mg
Arm Name:1

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description:Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd
Study Arm Type:Experimental
Arm Name:1
Description:Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Ranbaxy Laboratories Limited

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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