NCT00900237

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Partial Epilepsy

Interventions

Type	Name	Description
DRUG	Eslicarbazepine acetate	Oral administration 600 mg QD morning from Day 1-3 and 1200 mg 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)

Timeline

• Start date: 2008-11-01
• Primary completion: 2008-12-01
• Completion: 2009-02-01
• First posted: 2009-05-12
• Last updated: 2014-12-19
• Results posted: 2014-12-19

Locations

1 site across 1 country: Belgium