At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 120 enrolled
Drug / intervention
Oxcarbazepine +1 moredrug
Likely dose
Oxcarbazepine 600 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.
Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Oxcarbazepine 600 mg Tablet and Trileptal® Following a 600 mg Dose in Healthy Subjects Under Fed Conditions
In Brief
A Phase 1 clinical trial evaluating Oxcarbazepine and Trileptal® for Healthy. Completed, enrolled 120 participants across 1 site.
Detailed Summary
The objective of this study is to compare the rate and extent of absorption of a test formulation of oxcarbazepine tablets and Trileptal® tablets administered as a 1 x 600 mg dose under fed conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2005
Primary CompletionJul 2005
First PostedFeb 2009
TodayJul 2026
First PostedFeb 24, 2009
Enrollment StartJul 1, 2005
Primary CompletionJul 1, 2005
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Oxcarbazepinedrug
600 mg Tablet
Trileptal®drug
600 mg Tablet