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

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ClinicalTrials.gov Identifier: NCT00900237
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : December 19, 2014
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Partial Epilepsy Drug: Eslicarbazepine acetate Drug: Oxcarbazepine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Single Centre, Open, Randomised, Parallel Study to Evaluate the Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine in Healthy Subject
Study Start Date : November 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Eslicarbazepine acetate
Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9
 Drug: Eslicarbazepine acetate
Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9
Other Name: BIA 2-093
Active Comparator: Oxcarbazepine
Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9
 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)
Other Names:
  • Trileptal
  • Trexapin
  • 10,11-Dihydro-10-oxo-5 H -dibenz(b,f)azepine-5-carboxamide


Outcome Measures
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Primary Outcome Measures :
  1. Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid [ Time Frame: Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h ]
    Cmax - Maximum plasma concentration CSF - Cerebral Spinal Fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.

  2. AUC0-t AUC From Time Zero to the Last Sampling Time [ Time Frame: Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h ]
    AUC0-t - area under the concentration versus time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification CSF - cerebrospinal fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects
  • Aged 18-55 years
  • Body mass index (18.5-29 kg/m3)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900237


Locations
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Belgium
SGS LSS Clinical Pharmacology Unit Antwerpen
Antwerpen, Belgium, B-2060
Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
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Principal Investigator: Luc Cavens, MD SGS LSS Clinical Pharmacology Unit Antwerpen
More Information
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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00900237    
Other Study ID Numbers: BIA-2093-127
First Posted: May 12, 2009    Key Record Dates
Results First Posted: December 19, 2014
Last Update Posted: December 19, 2014
Last Verified: December 2014
Keywords provided by Bial - Portela C S.A.:
Partial
Epilepsy
Eslicarbazepine acetate
Pharmacokinetics
Tolerability
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eslicarbazepine acetate
Oxcarbazepine
 Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers