Back to resultsStudy to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine
Primary Purpose
Partial Epilepsy
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Eslicarbazepine acetate
Oxcarbazepine
Sponsored by
About this trial
This is an interventional treatment trial for Partial Epilepsy focused on measuring Partial, Epilepsy, Eslicarbazepine acetate, Pharmacokinetics, Tolerability
Eligibility Criteria
Inclusion Criteria:
- Healthy subjects
- Aged 18-55 years
- Body mass index (18.5-29 kg/m3)
Sites / Locations
- SGS LSS Clinical Pharmacology Unit Antwerpen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Eslicarbazepine acetate
Oxcarbazepine
Arm Description
Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9
Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9
Outcomes
Primary Outcome Measures
Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00900237
Brief Title
Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine
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 Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bial - Portela C S.A.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsy
Keywords
Partial, Epilepsy, Eslicarbazepine acetate, Pharmacokinetics, Tolerability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eslicarbazepine acetate
Arm Type
Active Comparator
Arm Description
Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9
Arm Title
Oxcarbazepine
Arm Type
Active Comparator
Arm Description
Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9
Intervention Type
Drug
Intervention Name(s)
Eslicarbazepine acetate
Other Intervention Name(s)
BIA 2-093
Intervention Description
Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9
Intervention Type
Drug
Intervention Name(s)
Oxcarbazepine
Other Intervention Name(s)
Trileptal, Trexapin, 10,11-Dihydro-10-oxo-5 H -dibenz(b,f)azepine-5-carboxamide
Intervention Description
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)
Primary Outcome Measure Information:
Title
Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid
Description
Cmax - Maximum plasma concentration CSF - Cerebral Spinal Fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.
Time Frame
Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h
Title
AUC0-t AUC From Time Zero to the Last Sampling Time
Description
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.
Time Frame
Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects
Aged 18-55 years
Body mass index (18.5-29 kg/m3)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Cavens, MD
Organizational Affiliation
SGS LSS Clinical Pharmacology Unit Antwerpen
Official's Role
Principal Investigator
Facility Information:
Facility Name
SGS LSS Clinical Pharmacology Unit Antwerpen
City
Antwerpen
ZIP/Postal Code
B-2060
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine
We'll reach out to this number within 24 hrs