At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
BIA 2-093 +1 moredrug
Likely dose
Not stated in 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.
Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating BIA 2-093 for Epilepsy. Completed, enrolled 40 participants.
Detailed Summary
Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female subjects, to demonstrate the bioequivalence (BE) between two active product ingredient (API) sources of eslicarbazepine acetate (ESL)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2010
Primary CompletionNov 2010
First PostedNov 2014
TodayJul 2026
First PostedNov 6, 2014
Enrollment StartOct 1, 2010
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 11.7 years ago
Interventions
BIA 2-093drug
MF - Marketed formulation
BIA 2-093drug
TBM - to-be-marketed