A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers
This study has been completed.
Sponsor:
Shire Development LLC
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00901576
First received: May 12, 2009
Last updated: June 30, 2010
Last verified: June 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: SPD503 Drug: Concerta Drug: SPD503 + Concerta |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Drug Reactions
Drug Information available for:
Methylphenidate
Methylphenidate hydrochloride
Guanfacine
Guanfacine hydrochloride
U.S. FDA Resources
Further study details as provided by Shire Development LLC:
Primary Outcome 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
| Enrollment: | 38 |
| Study Start Date: | May 2009 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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).
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| 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 More Information
Additional Information:
No publications provided
| Responsible Party: | Gerald Tremblay, MD, Shire Pharmaceutical |
| ClinicalTrials.gov Identifier: | NCT00901576 History of Changes |
| Other Study ID Numbers: | SPD503-114 |
| Study First Received: | May 12, 2009 |
| Results First Received: | April 16, 2010 |
| Last Updated: | June 30, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Shire Development LLC:
|
Healthy volunteers |
Additional relevant MeSH terms:
|
Methylphenidate Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013