A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

June 24, 2009

Primary Completion Date

July 30, 2009

Study Completion Date

July 30, 2009

Conditions
Healthy
Interventions
DRUG

SPD503

SPD503 extended-release 4mg orally administered tablets. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.

DRUG

VYVANSE

VYVANSE 50mg orally administered capsules. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.

DRUG

SPD503 and VYVANSE

SPD503 4mg tablets + VYVANSE 50mg capsules orally administered together. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.

Trial Locations (1)

Unknown

Advanced Biomedical Research, Inc., Hackensack

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY