At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
SPD544 +1 moredrug
Likely dose
SPD544 30mgfrom 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.
Phase 1,Randomized,Open-Label,Two Period Single Dose Crossover Bioequivalence Study of Two Capsule Strengths of SPD544 In Healthy Volunteers.
In Brief
A Phase 1 clinical trial evaluating SPD544 and Methylphenidate hydrochloride for ADHD. Completed, enrolled 28 participants across 1 site.
Detailed Summary
The purpose of this study is to assess bioequivalence of 2 capsule strengths.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2010
Enrollment StartAug 2010
Primary CompletionOct 2010
TodayJul 2026
First PostedAug 17, 2010
Enrollment StartAug 27, 2010
Primary CompletionOct 22, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.9 years ago
Interventions
SPD544drug
two 30mg capsules, single oral dose
Methylphenidate hydrochloridedrug
one 60mg capsule, single oral dose