Status:
COMPLETED
Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)
Lead Sponsor:
XenoPort, Inc.
Conditions:
Pharmacokinetics
Healthy Volunteer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 form...
Eligibility Criteria
Inclusion
- healthy, male and female subjects aged between 18 and 65 years old.
- normal body weight.
- normal ECG, vital signs and lab tests.
- normal kidney function
- agree to use acceptable contraceptive methods required.
- capable of giving written informed consent.
Exclusion
- positive blood alcohol or urine drug test.
- positive hepatitis B/C and HIV
- donation of more than 450 mL blood within the 56 days.
- sensitivity to gabapentin
- pregnant or lactating females
- smoker
- certain medical conditions including heart disease, psychiatric disease, gastrointestinal disease, kidney or liver dysfunction
- history of seizure
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00833391
Start Date
January 1 2009
End Date
March 1 2009
Last Update
May 14 2013
Active Locations (1)
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1
GSK Investigational Site
Evansville, Indiana, United States, 47710