NCT00865631

A Limited Food Effect Study of Gabapentin 800 mg Tablets

A Limited Food Effect Study of 800 mg Gabapentin Tablets Versus 400 mg Gabapentin Capsules

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin Tablets by Purepac Pharmaceutical Co. with that of 400 mg (2 x 400 mg) NEURONTIN® by Parke-Davis following a single oral dose (1 x 800 mg tablet) or (2 x 400 mg capsules) in healthy adult male volunteers under non-fasting conditions, and will compare the differences in plasma levels after dosing the test formulation with and without food.

Detailed description

Study Type: Interventional Study Design: Randomized, single-dose, three-way crossover under fed and fasting conditions Official Title: A Limited Food Effect Study of 800 mg Gabapentin Tablets versus 400 mg Gabapentin Capsules Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Gabapentin 800 mg tablets, single dose (1 tablet)	A: Experimental Subjects received Purepac formulated products under fasting conditions
DRUG	NEURONTIN® 400 mg capsules, single dose (2 capsules)	B: Active comparator Subjects received Parke-Davis formulated products under non-fasting conditions
DRUG	Gabapentin 800 mg tablets, single dose (1 tablet)	A: Experimental Subjects received Purepac formulated products under non-fasting conditions

Timeline

• Start date: 1999-06-01
• Primary completion: 1999-06-01
• Completion: 1999-06-01
• First posted: 2009-03-19
• Last updated: 2010-08-17

Locations

1 site across 1 country: United States