NCT02283840

Single Dose Crossover Comparative Bioavailability Study of Eslicarbazepine Acetate Versus To-be-marketed Formulation

Single Dose Crossover Comparative Bioavailability Study of Eslicarbazepine Acetate 400mg, 600mg and 800mg Tablets Clinical Trial Formulation (CTF) Versus the To-be-marketed Formulation (TBM) in Healthy Male and Female

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design

Detailed description

Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design to evaluate and compare the relative bioavailability and therefore the bioequivalence of three doses (400 mg, 600 mg and 800 mg) of eslicarbazepine acetate for two formulations (CTF versus TBM) after a single oral dose administration under fasting conditions

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	BIA 2-093

Timeline

• Start date: 2007-05-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2014-11-05
• Last updated: 2014-12-10
• Results posted: 2014-12-10