Skip to main content
OpenTrials
Completed

NCT Number: NCT00901576

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Advanced Biomedical Research, Inc.

Hackensack, New Jersey, 07601, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPD503

Drug

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

Other names: Intuniv

Concerta

Drug

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

SPD503 + Concerta

Drug

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

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of Guanfacine

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

  2. Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

  3. Time of Maximum Plasma Concentration (Tmax) of Guanfacine

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

  4. Time of Plasma Half-Life(T 1/2) of Guanfacine

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

  5. Cmax of d-Methylphenidate

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

  6. AUC of d-Methylphenidate

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

  7. Tmax of d-Methylphenidate

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

  8. T 1/2 of d-Methylphenidate

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 14, 2009
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.