Status:
COMPLETED
The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Epilepsy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Multiple-dose, open-label, single-period study consisting of three consecutive phases
Detailed Description
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 normalise...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2002
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02287415
Start Date
May 1 2002
End Date
July 1 2002
Last Update
December 1 2014
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