PP201—An Open-Label, Randomized, Single-Centre, Four-Way Crossover Study to Evaluate the Pharmacokinetics of Single, Oral Doses of Retigabine/Ezogabine in Healthy Adult Taiwanese Subjects

Abstract

Retigabine (RTG)/ezogabine, N-[2-amino-4(4-fluorobenzylamino)-phenyl] carbamic acid ethyl ester, is a novel antiepileptic compound. In 2011, RTG was approved by the FDA and European Commission as adjunctive treatment for partial onset seizures in adults aged ≥18 years. The global pivotal studies did not include Asian countries. The purpose of this study was to characterize the pharmacokinetics (PK) of single 50, 100, 200, and 400-mg doses of RTG and N-acetyl metabolites of RTG (NAMR) in healthy Taiwanese subjects.