A Drug Interaction Study of SPD503 and Concerta 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

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-18

Study Completion Date

2009-07-06

Brief Summary

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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.

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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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SPD503

Group Type EXPERIMENTAL

SPD503

Intervention Type DRUG

SPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets

Concerta

Group Type ACTIVE_COMPARATOR

Concerta

Intervention Type DRUG

CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets.

SPD503 + Concerta

Group Type ACTIVE_COMPARATOR

SPD503 + Concerta

Intervention Type DRUG

SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together).

Interventions

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SPD503

SPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets

Intervention Type DRUG

Concerta

CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets.

Intervention Type DRUG

SPD503 + Concerta

SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together).

Intervention Type DRUG

Other Intervention Names

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Intuniv

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 the screening visit

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes