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

Study Overview
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: SPD503
* Drug: Concerta
* Drug: SPD503 + Concerta


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPD503<br> | Drug: SPD503<br>* SPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets<br>* Other names: Intuniv;|
| Active Comparator: Concerta<br> | Drug: Concerta<br>* CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets.<br>|
| Active Comparator: SPD503 + Concerta<br> | Drug: SPD503 + Concerta<br>* SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) of Guanfacine |  | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | 
| Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine |  | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | 
| Time of Maximum Plasma Concentration (Tmax) of Guanfacine |  | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | 
| Time of Plasma Half-Life(T 1/2) of Guanfacine |  | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | 
| Cmax of d-Methylphenidate |  | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | 
| AUC of d-Methylphenidate |  | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | 
| Tmax of d-Methylphenidate |  | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | 
| T 1/2 of d-Methylphenidate |  | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers