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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT00900237
First received: May 11, 2009
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Partial Epilepsy
Drug: Eslicarbazepine acetate
Drug: Oxcarbazepine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • To evaluate the steady-state cerebrospinal fluid versus plasma concentrations of parent drug and metabolites following oral administration of eslicarbazepine acetate and oxcarbazepine to health volunteers [ Time Frame: 11 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the tolerability of eslicarbazepine acetate and oxcarbazepine following multiple oral dosing [ Time Frame: 16 days ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: November 2008
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects
  • Aged 18-55 years
  • Body mass index (18.5-29 kg/m3)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900237

Locations
Belgium
SGS LSS Clinical Pharmacology Unit Antwerpen
Antwerpen, Belgium, B-2060
Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
Principal Investigator: Luc Cavens, MD SGS LSS Clinical Pharmacology Unit Antwerpen
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00900237     History of Changes
Other Study ID Numbers: BIA-2093-127
Study First Received: May 11, 2009
Last Updated: June 18, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Bial - Portela C S.A.:
Partial
Epilepsy
Eslicarbazepine acetate
Pharmacokinetics
Tolerability

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Carbamazepine
Oxcarbazepine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 17, 2014