pharmacokinetic interaction study between eslicarbazepine acetate and carbamazepine

Conditions: Epilepsy

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.

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 criteria:
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; * 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.