NCT02284880

Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate

Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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)

Detailed description

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. The study consisted in 2 periods separated by a wash-out of at least 7 days between doses. To demonstrate the bioequivalence (BE) between two active product ingredient (API) sources \[current API source - marketed formulation (MF) versus new API source - to-be-marketed (TBM)\] of eslicarbazepine acetate (ESL)

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	BIA 2-093	MF - Marketed formulation
DRUG	BIA 2-093	TBM - to-be-marketed

Timeline

• Start date: 2010-10-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2014-11-06
• Last updated: 2015-01-12
• Results posted: 2015-01-12