Loading clinical trials...

COMPLETEDPHASE1

Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine

Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine in Healthy Subject

NCT02284854•Bial - Portela C S.A.

Summary

Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics.

Detailed Description

Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics. Each patient participated in the study for approximately 9 weeks. The clinical portion of the study was completed in approximately 3 months. Subjects received the treatments during 35 days.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male and female subjects aged 18 to 45 years inclusive;
•Body mass index (BMI) between 18 and 30 kg/m2 inclusive;
•Healthy as determined by pre-study medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG); negative tests for Hepatitis B surface Antigen (HBsAg), anti-HCVAb and Human Immunodeficiency Virus (HIV)-1 and HIV-2 Ab at screening;
•Clinical laboratory test results clinically acceptable at screening and admission to each treatment period;
•Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period;
•Non-smokers or ex-smokers;
•Able and willing to give written informed consent;
•If female, not of childbearing potential by reason of surgery or, if of childbearing potential, she used a double-barrier method of contraception: 1 male barrier method \[male condom\] plus 1 female barrier method (diaphragm, spermicide, or intrauterine device);
•If female, had a negative urine pregnancy test at screening and admission to each treatment period.

Exclusion Criteria

•Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders; have a clinically relevant surgical history;
•History of relevant atopy or any drug hypersensitivity (including known hypersensitivity to ESL or other carboxamide derivatives \[e.g., carbamazepine, oxcarbazepine\] or any of its excipients; known hypersensitivity to drugs structurally related to carbamazepine \[e.g.: tricyclic antidepressants\] or any of its excipients);
•Second or third-degree atrioventricular blockade not corrected with a pace-maker or any other clinically significant abnormality in the 12-lead ECG as determined by the investigator;
•History of alcoholism or drug abuse;
•Consumed more than 14 units1 of alcohol a week;
•Significant infection or known inflammatory process on screening or admission to each treatment period;
•Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period;
•Use of medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion;
•Had donated or received any blood or blood products within the 3 months prior to screening;
•Vegetarians, vegans or have other medical dietary restrictions;
+5 more criteria

Key Dates

Start Date

July 1, 2009

Primary Completion Date

November 1, 2009

Completion Date

November 1, 2009

Last Updated

January 8, 2015

Enrollment

ACTUAL participants

Conditions

Epilepsy

Interventions

BIA 2-093

DRUG

Carbamazepine

DRUG

Thalamus Seizure Detection With a Deep Brain Stimulator System

NCT06700356

Epilepsy; Seizure

View study

RECRUITINGPHASE1

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

NCT02531880

Epilepsy

View study

RECRUITINGNA

Intracranial Investigation of Neural Circuity Underlying Human Mood

NCT05871372

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

MEHMO Natural History and Biomarkers