NCT01878578

The Effect of BIA 2-093 on the Steady-state Pharmacokinetic Profile of Phenytoin in Patients

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is determine the interaction of eslicarbazepine acetate (ESL, BIA 2-093) on the steadystate pharmacokinetics of phenytoin in patients and to evaluate the tolerability and safety of ESL administered concomitantly with phenytoin in patients.

Detailed description

This study was planned as a single-dose, open label phase (Phase A) followed by a multiple-dose, double-blind, randomised, placebo-controlled, two-way crossover phase (Phase B) study in patients taking phenytoin. Phase B consisted of two 14-day treatment periods separated by a washout period of 10 to 15 days. Subjects continued their usual phenytoin scheme and received a single dose of ESL 1200 mg (Phase A) and either ESL (600 mg from Day 1 to 7 and 1200 mg from Day 8 to 14) or matching placebo once-daily for 14 days in each period. The study was prematurely terminated due to impossibility of recruiting the planned number of patients. Only 4 patients were admitted and this was considered a too small sample size to allow a reliable assessment of the potential interaction between ESL and phenytoin. Therefore, no pharmacokinetic evaluation was performed.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Eslicarbazepine acetate	Tablets containing ESL 600 mg
DRUG	phenytoin	Hidantina® tablets containing 100 mg of phenytoin
DRUG	Placebo	Tablets containing matching placebo

Timeline

• Start date: 2002-11-01
• Primary completion: 2003-03-01
• Completion: 2003-03-01
• First posted: 2013-06-17
• Last updated: 2014-02-27

Locations

1 site across 1 country: Portugal