Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine
Information source: Bial - Portela C S.A.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Partial Epilepsy
Intervention: Eslicarbazepine acetate (Drug); Oxcarbazepine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bial - Portela C S.A. Official(s) and/or principal investigator(s): Luc Cavens, MD, Principal Investigator, Affiliation: SGS LSS Clinical Pharmacology Unit Antwerpen
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal FluidAUC0-t AUC From Time Zero to the Last Sampling Time
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy subjects
- Aged 18-55 years
- Body mass index (18. 5-29 kg/m3)
Locations and Contacts
SGS LSS Clinical Pharmacology Unit Antwerpen, Antwerpen B-2060, Belgium
Additional Information
Starting date: November 2008
Last updated: December 12, 2014
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