At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 26 enrolled
Drug / intervention
Epanutin Infatabs (Phenytoin) +1 moredrug
Likely dose
Epanutin Infatabs (Phenytoin) 50 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.
An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study of Epanutin Infatabs 50 mg (Sourced From Germany) Verses Dilantin Infatabs 50 mg (Sourced From Australia) in Healthy Subjects
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted May 17, 2011·Updated Jan 28, 2021
In Brief
A Phase 1 clinical trial evaluating Epanutin Infatabs (Phenytoin) and Dilantin Infatabs (Phenytoin) for Healthy. Completed, enrolled 26 participants across 1 site.
Detailed Summary
In this study, the bioequivalence of Epanutin Infatabs® 50 mg (sourced from Germany) and Dilantin Infatabs® 50 mg (sourced from Australia) will be assessed. This is intended to be a pivotal bioequivalence study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSingapore
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedMay 2011
Primary CompletionJun 2011
TodayJul 2026
First PostedMay 17, 2011
Enrollment StartMay 1, 2011
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.1 years ago
Interventions
Epanutin Infatabs (Phenytoin)drug
Chewable Tablet, 50 mg, Single dose
Dilantin Infatabs (Phenytoin)drug
Chewable Tablet, 50 mg, Single dose