An Open Label, Randomised, Repeat Dose Study to Assess the Pharmacokinetic Performance of Five Ezogabine/Retigabine Modified Release (MR) Formulations at Steady State Compared to the Immediate Release (IR) Formulation.

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

February 10, 2011

Primary Completion Date

May 23, 2011

Study Completion Date

May 23, 2011

Conditions
Epilepsy
Interventions
DRUG

Investigational Medicinal Product (MR1)

Ezogabine MR1 at a dose strength of 300 mg will be orally administered with approximately 250 milliliter (mL) of water to group A subjects during the bioavailability phase. For the food effect phase subjects in group G will be orally administered MR1 tablets at a dose strength of 600 mg.

DRUG

Investigational Medicinal Product (MR2)

Ezogabine MR2 at a dose strength of 300 mg will be orally administered to group B subjects with approximately 250 mL of water during the bioavailability phase. For the food effect phase subjects in group H will be orally administered MR2 tablets at a dose strength of 600 mg.

DRUG

Investigational Medicinal Product (MR3)

Ezogabine MR3 will be orally administered with approximately 250 mL of water to group C subjects during the bioavailability phase. For the food effect phase subjects in group I will be orally administered MR3 tablets at a dose strength of 600 mg.

DRUG

Investigational Medicinal Product (MR4)

Ezogabine MR4 will be orally administered with approximately 250 mL of water to group D subjects during the bioavailability phase. For the food effect phase subjects in group J will be orally administered MR4 tablets at a dose strength of 600 mg.

DRUG

Investigational Medicinal Product (MR5)

Ezogabine MR5 will be orally administered with approximately 250 mL of water to group E subjects during the bioavailability phase. For the food effect phase subjects in group K will be orally administered MR5 tablets at a dose strength of 600 mg.

DRUG

Investigational Medicinal Product (IR)

Ezogabine IR at dose strengths of 50 mg and 200 mg will be orally administered with approximately 250 mL of water.

Trial Locations (1)

21225

GSK Investigational Site, Baltimore

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01332513 - An Open Label, Randomised, Repeat Dose Study to Assess the Pharmacokinetic Performance of Five Ezogabine/Retigabine Modified Release (MR) Formulations at Steady State Compared to the Immediate Release (IR) Formulation. | Biotech Hunter | Biotech Hunter