Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)
The purpose of this study is to evaluate the relative drug concentrations achieved with different formulations of GSK1838262 in healthy volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||An Open-label, Randomized, Single Dose, Five-period Crossover Study to Evaluate the Relative Bioavailability of Different Formulations of GSK1838262 in Healthy Volunteers.|
- gabapentin concentrations in blood [ Time Frame: measured up to 36 hr after dosing ] [ Designated as safety issue: No ]
- gabapentin concentrations in urine [ Time Frame: measured up to 36 hr after dosing ] [ Designated as safety issue: No ]
- Safety and tolerability as measured by adverse events, vital signs, ECGs and clinical laboratory tests. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Experimental: GSK1838262 arm
Each subject will participate in five dosing sessions separated by at least seven days. Subjects will receive a single dose of current formulation of GSK1838262 or one of the four new formulations of GSK1838262 at each dosing session in random sequence.
Drug: open label
This is an open-label, randomized, single-dose, five-period, crossover study. All subjects will receive GSK1838262.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833391
|United States, Indiana|
|GSK Investigational Site|
|Evansville, Indiana, United States, 47710|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|