NCT02283827

Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Phenytoin.

Phase I, Open-label Drug Interaction Study Between Eslicarbazepine Acetate 1200mg and Phenytoin 300 mg Following Multiple Dose Administrations in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Single centre, open-label, multiple doses, two parallel study groups each receiving two formulations in a one-sequence design

Detailed description

Single centre, open-label, multiple doses, two parallel study groups each receiving two formulations in a one-sequence design: Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of phenytoin (PHT) in last phases; Group B: Pre-treatment with PHT, treatment with PHT and ascending doses of ESL in last phases

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	BIA 2-093
DRUG	Phenytoin

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2014-11-05
• Last updated: 2014-12-18
• Results posted: 2014-12-18