The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin

• Status: Completed
• Trial end date: 2002-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Eslicarbazepine acetate; Warfarin

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