NCT00778401

Bioequivalence Study of Gabapentin 800 mg Tablets Under Fasting Conditions

A Relative Bioavailability Study of 800 mg Gabapentin Tablets Under Fasting Condition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (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 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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Gabapentin tablets 800 mg

Timeline

• Start date: 2002-10-01
• Primary completion: 2002-10-01
• Completion: 2002-12-01
• First posted: 2008-10-23
• Last updated: 2008-10-23

Locations

1 site across 1 country: United States