NCT00778232

Bioequivalence Study of Gabapentin 800 mg Tablets Under Fed Conditions

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Gabapentin tablets 800 mg

Timeline

• Start date: 2002-10-01
• Primary completion: 2002-11-01
• Completion: 2002-11-01
• First posted: 2008-10-23
• Last updated: 2008-10-23

Locations

1 site across 1 country: United States