The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 2-093; Warfarin
Intervention MeSH terms: Eslicarbazepine acetate; Warfarin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Multiple-dose, open-label, single-period study consisting of three consecutive phases
    

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