drugset / Trial / NCT01691872

Pharmacokinetic Study of Retigabine Extended Release (XR) Formulation in Healthy Adult Japanese and Caucasian Subjects

NCT01691872 ↗

Phase 1 Withdrawn GlaxoSmithKline
Non-randomizedParallel-groupOpen-labelOther

Summary

This is an open-label, single centre, parallel group study to evaluate the safety and pharmacokinetics of single oral doses of retigabine XR formulation in healthy adult Japanese subjects. To compare the pharmacokinetic and safety profile, Caucasian subjects are also incorporated. This study is intended to facilitate inclusion of Japanese patients in the global phase III program for retigabine XR formulation.

Timeline

Start
2012-10-10
Primary completion
2012-10-18
Completion
2012-10-18

Outcome

Outcome not reported

Stopped: “Development plan of retigabine XR in Japan was readjusted.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezogabine Small molecule 300 mg Oral

Indications