CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Eslicarbazepine acetate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00987558
NCT00987558Phase 1Completed
CompareCT.gov

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

Bial - Portela C S.A.·interventional·Posted Oct 1, 2009·Updated Jan 13, 2015

In Brief

A Phase 1 clinical trial evaluating Eslicarbazepine acetate and Simvastatin for Epilepsy. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesFrance
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 1, 2009
Enrollment StartJun 1, 2009
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.8 years ago

Interventions

Eslicarbazepine acetatedrug

Simvastatindrug