Status:
COMPLETED
Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Epilepsy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 pa...
Eligibility Criteria
Inclusion
- 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
- 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;
- Could not communicate reliably with the investigator; was unlikely to co-operate with the requirements of the study;
- Unwilling or unable to give written informed consent;
- If female, was pregnant or breast-feeding;
- If female, was of childbearing potential and did not use an accepted effective contraceptive method or used hormonal contraceptives;
- Had received an investigational drug within 3 months of screening or was currently participating in another study.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02284854
Start Date
July 1 2009
End Date
November 1 2009
Last Update
January 8 2015
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