NCT00778271

Bioequivalence Study of Gabapentin 400 mg Capsules Under Fasting Conditions

Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Ranbaxy and Park:-Davis (Neurontin®) 400 mg Gabapentin Capsules in Healthy Adult Volunteers Under Fasting Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Parke-Davis (Neurontin®) 400 mg Gabapentin, following administration of a 400 mg dose under fasting conditions

Detailed description

This was an open-label, randomized, single-dose, 2-way crossover relative bioavailability study performed on 24 healthy adult volunteers and 2 alternates. A total of 26 subjects (22 males and 4 females) completed the clinical phase of the study. In each period, subjects were housed from at least 10 hours before dosing until after the 36-hour blood draw. Both periods were separated by a wash out period of 7 days A total of 26 healthy adult volunteers (22 males and 4 non-pregnant females) enrolled in and completed the clinical phase of the study enrolled in and completed the clinical phase of the study

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Gabapentin 400mg capsules

Timeline

• Start date: 2002-09-01
• 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: Canada