NCT00833391

Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)

An Open-label, Randomized, Single Dose, Five-period Crossover Study to Evaluate the Relative Bioavailability of Different Formulations of GSK1838262 in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: XenoPort, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the relative drug concentrations achieved with different formulations of GSK1838262 in healthy volunteers.

Detailed description

This is an open-label, randomized, single-dose, five-period, crossover study to evaluate the relative drug concentrations with different formulations of GSK1838262 in healthy volunteers. Four new formulations will be tested against the current formulation to identify the most promising new formulations for further development. Each subject will participate in five dosing periods and each period will be separated by at least seven days. Blood and urine samples will be collected over the 36 hour period following each dose administration to measure the drug concentrations.

Conditions

• Pharmacokinetics
• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	open label	This is an open-label, randomized, single-dose, five-period, crossover study. All subjects will receive GSK1838262.

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2009-02-02
• Last updated: 2013-05-14

Locations

1 site across 1 country: United States