MedTrace Logo

Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects

NCT00987558 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-01-13

Study results available
· View outcomes & findings →

Summary

The primary objective was to investigate whether multiple-dose administration of ESL 800 mg once daily affects the pharmacokinetics of simvastatin, a substrate of CYP34A.

Conditions

Interventions

DRUG

Eslicarbazepine acetate

DRUG

Simvastatin

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Principal Investigators

  • Marie Claude Homery, MD · Biotrial, 7-9, rue Jean-Louis Bertrand, F-35000 Rennes, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • France

Study Locations

More Related Trials

Entities

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 NCT00987558 on ClinicalTrials.gov