Bioequivalence Study of Gabapentin 800 mg Tablets Under Fed Conditions

Completed · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00778232

Run by

Ranbaxy Laboratories Limited

People needed

22

Starts

2002-10-01

Expected to finish

2002-11-01

Last updated by the study team

2008-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All volunteers selected for the study will be healthy men or women 18 years of age or older at the time of dosing
• The weight will no exceed ± 20% for the height and body frame as per desirable weight for adults - 1983 Metropolitan height and weight table
• 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)

You may not qualify if…

• volunteers with a recent history of drug or alcohol addiction or abuse
• 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)
• Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant
• Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen
• Volunteers demonstrating a positive drug abuse screen when screened for this study
• Female volunteers demonstrating a positive pregnancy screen
• Female volunteers who are currently breast feeding
• Volunteers with a history of allergic response (s) to Gabapentin or related drugs
• Volunteers with a history of clinically significant allergies including drug allergies
• Volunteers with a clinically significant illness during the 4 weeks prior to period I dosing (as determined by the clinical investigators)
• Volunteers who are currently using tobacco products
• Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to period I dosing
• 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
• 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
• Volunteers who report receiving any investigational drug within 30 days prior to period I dosing
• Volunteers who report taking any systemic prescription medication in the 14 days prior to period I dosing.

Where it is running

• PRACS Institute Ltd. — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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