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

ClinicalTrials.gov ID: NCT00901576

Public ClinicalTrials.gov record NCT00901576. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 5:23 AM EDT

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Official title

A Phase 1, Open-label, Randomized, Three-period Crossover Drug Interaction Study Evaluating the Pharmacokinetic Profiles of SPD503 and CONCERTA, Administered Alone and in Combination in Healthy Adult Volunteers

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00901576
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Shire; Industry
Enrollment: 38 participants

Conditions and interventions

Conditions

Healthy

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 45 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 17, 2009
Primary completion: Jul 5, 2009
Completion: Jul 5, 2009
Last update posted: Jun 13, 2021

2009

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Advanced Biomedical Research, Inc.	Hackensack	New Jersey	07601	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00901576, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 13, 2021 · Synced Sep 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00901576 live on ClinicalTrials.gov.

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