At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Dexmethylphenidate Hydrochloride +1 moredrug
Likely dose
Dexmethylphenidate Hydrochloride 10 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 Randomized, Two-Way, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Dexmethylphenidate Hydrochloride, (10 mg), Compared to an Equivalent Dose of a Commercially Available Reference Product (Focalin®, Novartis Pharmaceuticals Corporation) in 24 Fed, Healthy, Adult Subjects
In Brief
A Phase 1 clinical trial evaluating Dexmethylphenidate Hydrochloride for Healthy. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral dose of the commercially available dexmethylphenidate hydrochloride (Focalin®, Novartis Pharmaceuticals Corporation) in a test population of 24 adult subjects under fed conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2004
Primary CompletionJun 2004
First PostedJan 2009
TodayJul 2026
First PostedJan 27, 2009
Enrollment StartJun 1, 2004
Primary CompletionJun 1, 2004
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Dexmethylphenidate Hydrochloridedrug
10 mg Tablet
Dexmethylphenidate Hydrochloridedrug
10 mg Tablet