Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: XenoPort, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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