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

NCT01878578 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2014-02-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Eslicarbazepine acetate

Tablets containing ESL 600 mg

DRUG

phenytoin

Hidantina® tablets containing 100 mg of phenytoin

DRUG

Placebo

Tablets containing matching placebo

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2003-03-31
Completion
2003-03-31

Countries

  • Portugal

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01878578 on ClinicalTrials.gov