Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)

Completed · Phase 1

Conditions studied: Pharmacokinetics, Healthy Volunteer

In brief

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

Key facts

Study ID

NCT00833391

Run by

XenoPort, Inc.

People needed

16

Starts

2009-01-01

Expected to finish

2009-03-01

Last updated by the study team

2013-05-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

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