At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 22 enrolled
Drug / intervention
Primidone 50 mg Tablet +1 moredrug
Likely dose
Primidone 50 mg Tabletfrom 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 Primidone 50 mg, Compared to an Equivalent Dose of Primidone (Mysoline®) in Healthy Adult Subjects
In Brief
A Phase 1 clinical trial evaluating Primidone 50 mg Tablet and Primidone (Mysoline®) 50 mg Tablet for Therapeutic Equivalency. Completed, enrolled 22 participants.
Detailed Summary
The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline®(primidone tablets) in adult subjects under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTherapeutic Equivalency
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2004
Primary CompletionJun 2004
First PostedMay 2008
TodayJul 2026
First PostedMay 28, 2008
Enrollment StartMay 1, 2004
Primary CompletionJun 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 18.1 years ago
Interventions
Primidone 50 mg Tabletdrug
50 mg tablet administered after an overnight fast of at least 10 hours.
Primidone (Mysoline®) 50 mg Tabletdrug
50 mg tablet administered after an overnight fast of at least 10 hours.