drugset / Trial / NCT01691872
Pharmacokinetic Study of Retigabine Extended Release (XR) Formulation in Healthy Adult Japanese and Caucasian Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ezogabine | Small molecule | 300 mg | Oral |