the effect of bia 2-093 on the steady-state pharmacokinetics of digoxin

Conditions: Epilepsy

Summary: the purpose of this study is to investigate the effects of multiple-dose administration of bia 2-093 on the steady-state pharmacokinetics of digoxin in healthy subjects.

single centre, multiple-dose, double-blind, randomised, placebo-controlled, two-way crossover study in 12 healthy volunteers. the study consisted of two 8-day treatment periods separated by a washout of 10 or more days. during each of the treatment periods the volunteers received either a daily oral dose of bia 2-093 1200 mg once-daily (od) or matching placebo, concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).

Eligibility criteria:
inclusion criteria: * male or female subjects aged between 18 and 45 years, inclusive. * subjects of body mass index (bmi) between 19 and 28 kg/m2, inclusive. * subjects who were healthy as determined by pre-study medical history, physical examination, neurological examination, and 12-lead ecg. * subjects who had clinical laboratory tests clinically acceptable. * subjects who were negative for hbs ag, anti-hcv ab and anti-hiv-1 and hiv-2 ab tests at screening. * subjects who were negative for alcohol and drugs of abuse at screening. * subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day. * subjects who were able and willing to give written informed consent. * in case of female volunteers, subjects who were not of childbearing potential by reason of surgery or, if of childbearing potential, used one of the following methods of contraception: double-barrier or intrauterine device. * in case of female volunteers, subjects who had a negative pregnancy test at screening. exclusion criteria: * subjects who did not conform to the above inclusion criteria. * subjects who had a 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. * subjects who had a clinically relevant surgical history. * subjects who had a clinically relevant family history. * subjects who had a history of relevant atopy. * subjects who had a history of relevant drug hypersensitivity. * subjects who had a history of alcoholism or drug abuse. * subjects who consumed more than 14 units of alcohol a week. * subjects who had any of the following findings on the ecg: qtc interval \>440 msec; first-, second- or third-degree atrioventricular block; atrial fibrillation; heart rate below 50 bpm; any other relevant abnormality. * subjects who had a significant infection or known inflammatory process on screening and/or admission. * subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn). * subjects who had used prescription drugs within 4 weeks of first dosing. * subjects who had used over the counter medication excluding oral routine vitamins but including mega dose vitamin therapy within one week of first dosing. * subjects who had used any investigational drug and/or participated in any clinical trial within 2 months of their first admission. * subjects who had previously received bia 2-093. * subjects who had donated and/or received any blood or blood products within the previous 2 months prior to screening. * subjects who were vegetarians, vegans and/or had medical dietary restrictions. * subjects who could not communicate reliably with the investigator. * subjects who were unlikely to co-operate with the requirements of the study. * subjects who were unwilling or unable to give written informed consent. * in case of female volunteers, subjects who were pregnant or breast-feeding. * in case of female volunteers, subjects who were of childbearing potential and did not use an authorized effective contraceptive method.

Keywords: eslicarbazepine acetate bia 2-093