Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine
This study has been completed.
Sponsor:
Bial - Portela C S.A.
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT00900237
First received: May 11, 2009
Last updated: June 18, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Partial Epilepsy |
Drug: Eslicarbazepine acetate Drug: Oxcarbazepine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
autosomal dominant partial epilepsy with auditory features
pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics:
Epilepsy
Drug Information available for:
Oxcarbazepine
U.S. FDA Resources
Further study details as provided by Bial - Portela C S.A.:
Primary Outcome Measures:
- To evaluate the steady-state cerebrospinal fluid versus plasma concentrations of parent drug and metabolites following oral administration of eslicarbazepine acetate and oxcarbazepine to health volunteers [ Time Frame: 11 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the tolerability of eslicarbazepine acetate and oxcarbazepine following multiple oral dosing [ Time Frame: 16 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 12 |
| Study Start Date: | November 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Eslicarbazepine acetate
Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9
|
Drug: Eslicarbazepine acetate
Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9
Other Name: BIA 2-093
|
|
Active Comparator: Oxcarbazepine
Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID 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)
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy subjects
- Aged 18-55 years
- Body mass index (18.5-29 kg/m3)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900237
Locations
| Belgium | |
| SGS LSS Clinical Pharmacology Unit Antwerpen | |
| Antwerpen, Belgium, B-2060 | |
Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
| Principal Investigator: | Luc Cavens, MD | SGS LSS Clinical Pharmacology Unit Antwerpen |
More Information
No publications provided
| Responsible Party: | Bial - Portela C S.A. |
| ClinicalTrials.gov Identifier: | NCT00900237 History of Changes |
| Other Study ID Numbers: | BIA-2093-127 |
| Study First Received: | May 11, 2009 |
| Last Updated: | June 18, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by Bial - Portela C S.A.:
|
Partial Epilepsy Eslicarbazepine acetate Pharmacokinetics Tolerability |
Additional relevant MeSH terms:
|
Epilepsy Epilepsies, Partial Brain Diseases Central Nervous System Diseases Nervous System Diseases Carbamazepine Oxcarbazepine Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 22, 2013