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Crossover Study to Evaluate the Pharmacokinetics of Ezogabine/Retigabine in Taiwanese Subjects

NCT01462669 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-06-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

50mg Ezogabine/retigabine

A single 50mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state

DRUG

100mg Ezogabine/retigabine

A single 100mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state

DRUG

200mg Ezogabine/retigabine

A single 200mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state

DRUG

400mg Ezogabine/retigabine

A single 400mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-10
Primary Completion
2012-06-27
Completion
2012-06-27

Countries

  • Taiwan

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01462669 on ClinicalTrials.gov