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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-24

Study Completion Date

2009-07-30

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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A: SPD503 (4mg)

Group Type ACTIVE_COMPARATOR

SPD503

Intervention Type DRUG

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.

B: VYVANSE (50mg)

Group Type ACTIVE_COMPARATOR

VYVANSE

Intervention Type DRUG

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.

C: SPD503 (4mg) + VYVANSE (50mg)

Group Type ACTIVE_COMPARATOR

SPD503 and VYVANSE

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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guanfacine hydrochloride lisdexamfatamine dimesylate (LDX)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes