Trials / Completed
CompletedNCT00987558
Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Bial - Portela C S.A. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Detailed description
This was a single centre, two-way crossover, randomised, open-label study in 24 healthy volunteers. The volunteers will receive an oral single-dose of simvastatin 80 mg on two occasions - once administered alone and once after treatment with an oral once-daily dose of 800 mg of ESL for 14 days -, separated by a washout period of 3 weeks or more
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Eslicarbazepine acetate | |
| DRUG | Simvastatin |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2009-08-01
- Completion
- 2009-08-01
- First posted
- 2009-10-01
- Last updated
- 2015-01-13
- Results posted
- 2015-01-13
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00987558. Inclusion in this directory is not an endorsement.