the effect of bia 2-093 on the steady-state pharmacodynamic and pharmacokinetic profiles of warfarin

Conditions: Epilepsy

Summary: multiple-dose, open-label, single-period study consisting of three consecutive phases

multiple-dose, open-label, single-period study consisting of three consecutive phases: phase a - run-in warfarin dose-finding phase phase b - warfarin pharmacokinetics (pk) and international normalised ratio (inr) profiling phase c - warfarin alone at their individualised doses

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 current haemostatic disorder or a personal or family history of any such disorder * subjects who had a personal or family history of bleeding complications after surgery or tooth extraction, nose or gingival bleeding, or haemorrhagic diathesis. * subjects with a profession or activities implying a special risk of trauma * subjects with any abnormality in the coagulation status (aptt or prothrombin inr) * 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 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 2 weeks prior admission on phase a * subjects who had used any investigational drug and/or participated in any clinical trial within 2 months prior admission to phase a * 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 admission to phase a * subjects who were vegetarians, vegans and/or had medical dietary restrictions * subjects who could not communicate reliably with the investigator