Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate

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)

Timeline

Start

2010-10

Primary completion

2010-11

Completion

2010-11

Drugs

Indications