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Completed

NCT Number: NCT00900237

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

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.

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Key information

Conditions

Partial Epilepsy Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SGS LSS Clinical Pharmacology Unit Antwerpen

Antwerp, B-2060, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects
  • Aged 18-55 years
  • Body mass index (18.5-29 kg/m3)

Treatment and study plan

eslicarbazepine acetate

Drug

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

Other names: BIA 2-093

Oxcarbazepine

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)

Other names: Trileptal, Trexapin, 10,11-Dihydro-10-oxo-5 H -dibenz(b,f)azepine-5-carboxamide

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bial - Portela C S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
May 12, 2009
Registry last updated
Dec 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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