NCT00778765

Bioequivalence Study of Gabapentin 400 mg Capsules Under Fed Conditions

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To compare the single-dose oral bioavailability of metformin HCI liquid 500 mg/5 mL of Ranbaxy with Glucophage® 1000 mg tablets of Bristol-Myers, USA following administration of a 1000 mg dose in healthy, adult, male and female volunteers 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. All 26 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 36-hour blood draw. Single oral 400 mg doses were separated by a washout period of 7 days A total of 24 healthy adult volunteers and 2 alternates (17 males and 9 non-pregnant females) enrolled in and completed the clinical phase of the study

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	400 mg Gabapentin 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