NCT02288312

Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate

Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate Market Formulation in Healthy Volunteers

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

Summary

Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects.

Detailed description

Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects. The study consisted of 3 periods separated by a washout of 7 days or more between doses. Subjects received a single oral 800 mg dose of eslicarbazepine acetate following a standard meal in one period, and following at least 10 hours of fasting in two periods.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	BIA 2-093

Timeline

• Start date: 2007-05-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2014-11-11
• Last updated: 2015-01-08
• Results posted: 2015-01-08