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

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”

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.

Intervention(s) in this Clinical Trial

• Drug: SPD503
  • SPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets
• Drug: Concerta
  • CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets.
• Drug: SPD503 + Concerta
  • SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together).

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: SPD503
• Active Comparator: Concerta
• Active Comparator: SPD503 + Concerta

Primary Measures

• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Shire Pharmaceutical Development Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00901576

Study ID Number: SPD503-114

ClinicalTrials.gov Identifier: NCT00901576

Health Authority: United States: Food and Drug Administration

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