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

Phase 1

Completed

• Conditions: Partial Epilepsy
• Interventions: Drug: Oxcarbazepine; Drug: Eslicarbazepine acetate

• Registration Number: NCT00900237
• Lead Sponsor: Bial - Portela C S.A.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2008-12
• Study Completion: 2009-02
• Study First Submitted: 2009-05-11
• Study First Submitted QC: 2009-05-11
• Study First Posted: 2009-05-12
• Status Verified: 2014-12
• Results First Submitted: 2014-12-04
• Results First Submitted QC: 2014-12-12
• Last Update Submitted: 2014-12-12
• Results First Posted: 2014-12-19
• Last Update Posted: 2014-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxcarbazepine	Oxcarbazepine	Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9
Eslicarbazepine acetate	Eslicarbazepine acetate	Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9

Primary Outcome Measures

Name	Time	Method
Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid	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.
AUC0-t AUC From Time Zero to the Last Sampling Time	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.

Trial Locations

Locations (1)

SGS LSS Clinical Pharmacology Unit Antwerpen; 🇧🇪 Antwerpen, Belgium