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Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine

NCT ID: NCT00900237

Last Updated: 2014-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-02-28

Brief Summary

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This purpose of this study is to measure the concentrations of two anti-epileptic drugs (Eslicarbazepine acetate and oxcarbazepine) and their metabolites in the cerebrospinal fluid and blood plasma of healthy subjects and also to assess how these drugs are tolerated.

Detailed Description

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Conditions

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Partial Epilepsy

Keywords

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Partial Epilepsy Eslicarbazepine acetate Pharmacokinetics Tolerability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Eslicarbazepine acetate

Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9

Group Type ACTIVE_COMPARATOR

Eslicarbazepine acetate

Intervention Type DRUG

Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9

Oxcarbazepine

Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9

Group Type ACTIVE_COMPARATOR

Oxcarbazepine

Intervention Type DRUG

Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)

Interventions

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Eslicarbazepine acetate

Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9

Intervention Type DRUG

Oxcarbazepine

Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)

Intervention Type DRUG

Other Intervention Names

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BIA 2-093 Trileptal Trexapin 10,11-Dihydro-10-oxo-5 H -dibenz(b,f)azepine-5-carboxamide

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects
* Aged 18-55 years
* Body mass index (18.5-29 kg/m3)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bial - Portela C S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luc Cavens, MD

Role: PRINCIPAL_INVESTIGATOR

SGS LSS Clinical Pharmacology Unit Antwerpen

Locations

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SGS LSS Clinical Pharmacology Unit Antwerpen

Antwerp, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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BIA-2093-127

Identifier Type: -

Identifier Source: org_study_id