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

Shire

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: SPD503 + Concerta; Drug: SPD503; Drug: Concerta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00901576

SPD503-114

Details and patient eligibility

About

This is a drug-drug interaction study; the purpose of this study is to examine the pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and Concerta (methylphenidate HCl) when given alone, and in combination.

Enrollment: 38 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 the screening visit

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 3 patient groups

SPD503

Experimental group

Treatment:

Drug: SPD503

Concerta

Active Comparator group

Treatment:

Drug: Concerta

SPD503 + Concerta

Active Comparator group

Treatment:

Drug: SPD503 + Concerta