NCT02284854

Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine

Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine in Healthy Subject

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics.

Detailed description

Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics. Each patient participated in the study for approximately 9 weeks. The clinical portion of the study was completed in approximately 3 months. Subjects received the treatments during 35 days.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	BIA 2-093
DRUG	Carbamazepine

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2014-11-06
• Last updated: 2015-01-08
• Results posted: 2015-01-08