NCT00864305

A Relative Bioavailability Study of Gabapentin 400 mg Capsules Under Non-fasting Conditions

• 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

To compare the relative bioavailability of gabapentin 400 mg capsules (Purepac) with that of NEURONTIN® 400 mg capsules (Parke-Davis) in healthy adult male subjects under non-fasting conditions, and to compare the differences in plasma levels after dosing the test formulation with and without food

Detailed description

Study Type: Interventional Study Design: Single dose, randomized, three-period, three-treatment, six-sequence crossover study under non-fasting conditions (test and reference) and fasting (test) conditions Official Title: A relative Bioavailability Food Challenge Study of Gabapentin 400 mg 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 400 mg capsules	A: Experimental Subjects received Purepac formulated products under fed conditions
DRUG	NEURONTIN® 400 mg capsules	B: Active comparator Subjects received Parke-Davis's marketed product
DRUG	Gabapentin 400 mg capsules, single dose	C: Experimental Subjects received Purepac formulated products under fasting conditions

Timeline

• Start date: 1997-12-01
• Primary completion: 1998-01-01
• Completion: 1998-01-01
• First posted: 2009-03-18
• Last updated: 2010-08-17

Locations

1 site across 1 country: United States