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

Shire

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: SPD503 and VYVANSE; Drug: SPD503; Drug: VYVANSE

Study type: Interventional

Funder types: Industry

Identifiers

NCT00919867

SPD503-115

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

A: SPD503 (4mg)

Active Comparator group

Treatment:

Drug: SPD503

B: VYVANSE (50mg)

Active Comparator group

Treatment:

Drug: VYVANSE

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

Active Comparator group

Treatment:

Drug: SPD503 and VYVANSE