Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine

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;
• •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.