Crossover Study to Evaluate the Pharmacokinetics of Ezogabine/Retigabine in Taiwanese Subjects
Status:
Completed
Trial end date:
2012-06-27
Target enrollment:
Participant gender:
Summary
The purpose of this study is to investigate the pharmacokinetics of single oral doses of
ezogabine/retigabine and the primary metabolite (NAMR) in healthy male and female Taiwanese
volunteers. Subjects will receive four separate doses of ezogabine/retigabine tablets: 50 mg,
100 mg, 200 mg and 400 mg administered once orally. Blood samples will be obtained at
pre-defined timepoints over the duration of the study to determine the concentration of
ezogabine/retigabine and NAMR. Safety assessments will include measurements of vital signs,
collection of adverse events, clinical laboratory tests and the Columbia Suicide Severity
Rating Scale.