At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 38 enrolled
Drug / intervention
SPD503 +2 moredrug
Likely dose
SPD503 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating SPD503, Concerta, and 1 other intervention for Healthy. Completed, enrolled 38 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2009
Enrollment StartMay 2009
Primary CompletionJul 2009
TodayJul 2026
First PostedMay 14, 2009
Enrollment StartMay 18, 2009
Primary CompletionJul 6, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.1 years ago
Interventions
SPD503drug
SPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets
Concertadrug
CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets.
SPD503 + Concertadrug
SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together).