Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects

This is an interventional treatment trial for Epilepsy focused on measuring Eslicarbazepine acetate, simvastatin Read More

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 ECG; negative tests for HBsAg, anti-HCVAb and 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 uses one of the following methods of contraception: double barrier method: 1 male barrier method [male condom] plus 1 female barrier method (diaphragm, spermicide, or intrauterine device);
• If female, has 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
• Clinically relevant surgical history;
• History of relevant atopy or any drug hypersensitivity (including known hypersensitivity to ESL or other carboxamide derivatives, simvastatin or other statins or any of its excipients
• History of fibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain
• Second or third-degree atrioventricular blockade not corrected with a pacemaker or any other clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator
• History of alcoholism or drug abuse
• Consume more than 14 units 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
• Have donated or received any blood or blood products within the 3 months prior to screening
• Vegetarians, vegans or have other medical dietary restrictions
• Cannot communicate reliably with the investigator
• Unlikely to co-operate with the requirements of the study
• Unwilling or unable to give written informed consent
• If female, is pregnant or breast-feeding
• If female, is of childbearing potential and does not use an approved effective contraceptive method (double-barrier method: 1 male barrier method [male condom] plus 1 female barrier method (diaphragm, spermicide, or intra-uterine device) or uses hormonal contraceptives
• Have received an investigational drug within 3 months of screening or is currently participating in another study