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

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ClinicalTrials.gov Identifier: NCT00901576
Recruitment Status : Completed
First Posted : May 14, 2009
Results First Posted : May 19, 2010
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: SPD503 Drug: Concerta Drug: SPD503 + Concerta Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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
Study Start Date : May 2009
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: SPD503 Drug: SPD503
SPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets
Other Name: Intuniv
Active Comparator: Concerta Drug: Concerta
CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets.
Active Comparator: SPD503 + Concerta Drug: SPD503 + Concerta
SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together).


Outcome Measures

Primary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901576


Locations
United States, New Jersey
Advanced Biomedical Research, Inc.
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Shire
More Information

Additional Information:
Publications:
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00901576     History of Changes
Other Study ID Numbers: SPD503-114
First Posted: May 14, 2009    Key Record Dates
Results First Posted: May 19, 2010
Last Update Posted: February 6, 2014
Last Verified: January 2014

Keywords provided by Shire:
Healthy volunteers

Additional relevant MeSH terms:
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents