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

Phase 1CompletedNCT00919867

Shire42 enrolled

Overview

Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE (lisdexamfetamine dimesylate) when given alone, and in combination.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

SPD503DRUG

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.

VYVANSEDRUG

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.

SPD503 and VYVANSEDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects must be normal healthy adult volunteers (with no significant abnormalities in medical history, physical exam, vital signs or lab evaluations at screening) in order to be eligible to participate.

Locations (1)

Advanced Biomedical Research, Inc.

Hackensack, New Jersey, United States