Overview

Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate

Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
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)
Phase:
Phase 1
Details
Lead Sponsor:
Bial - Portela C S.A.
Treatments:
Eslicarbazepine acetate