A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers
- Registration Number
- NCT00901576
- Lead Sponsor
- Shire
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description SPD503 + Concerta SPD503 + Concerta - SPD503 SPD503 - Concerta Concerta -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Advanced Biomedical Research, Inc.
🇺🇸Hackensack, New Jersey, United States