Phase 1
Completed N=14
Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine
Partial Epilepsy
Source: ClinicalTrials.gov NCT00900237 ↗
Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid — 23932; 16162; 886; 4039 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid |
23932; 16162; 886; 4039; 245; 1990 | — |
| PRIMARY AUC0-t AUC From Time Zero to the Last Sampling Time |
340123; 164726; 18743; 39034; 3377; 7135 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy subjects
- Aged 18-55 years
- Body mass index (18.5-29 kg/m3)
Data sourced from ClinicalTrials.gov (NCT00900237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.