EUCTR2007-005037-11-GB进行中（未招募）不适用
An open-label, randomized 2-period crossover study to investigate the pharmacodynamics, pharmacokinetics, safety and tolerability of warfarin in combination with oseltamivir in volunteers stabilized on warfarin therapy.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female subjects, 18-85 years of age, inclusive.
- •2. Subjects must have been receiving warfarin once daily for at least 4 weeks prior
- •to screening.
- •3. Subjects must have regular INR monitoring during warfarin therapy prior to study
- •entry, and willing to be trained in the use of CoaguChek® devices.
- •4. INR must fall within a target range of 2.0-3.5 (as determined by
- •CoaguChek® or a clinical laboratory INR test).
- •5. A BMI between 18-32 kg/m2 inclusive
- •6. Able to participate, and willing to give written informed consent and to comply
- •with the study restrictions
- •7. Confirmation by dietician questionnaire of a reasonably balanced diet
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. An INR value between screening and Day -1 lower than 2.0 or greater than 3.5.
- •2. A change in their prescribed daily warfarin dose between screening and Day -1.
- •3. History of any coagulopathy for example von Willebrand’s disease.
- •4. Consumption of health products or supplements containing Vitamin K.
- •5. If capable of reproduction, unwilling to use an effective (barrier) form of
- •contraception (post-menopausal status must be verified by negative hormone
- •6. Positive pregnancy test at screening or Day -1 and lactating women.
- •7. Confirmed positive urine and/or blood test for drugs of abuse at screening or
- •8. History of drug or alcohol abuse.
- •9. Donation or loss of blood over 500 mL within three months prior to screening.
- •10. Participation in an investigational drug or device study within three months prior
- •to screening.
- •11. Smokers of >5 cigarettes or equivalent in tobacco per day (>3 pipefulls or
- •>3 cigars per day).
- •12. Use of any prescription drug, over the counter medication or herbal product,
- •known to be an inducer or inhibitor of CYP450 enzymes or any drugs included in
- •the list of prohibited medications, taken within 7 days of first dose of study drug,
- •or 5 times the elimination half-life of the medication, whichever is longer, unless
- •the patient/volunteer is stable on the stated medication and it has been taken
- •for a period of = 3 months.
- •13. Consistent supine systolic blood pressure (SBP) greater than 160 or less than 80
- •and diastolic blood pressure (DBP) greater than 90 or less than 60 mm Hg
- •between screening and Day -1.
- •14. Consistent supine heart rate (HR) at rest greater than 90 less than 45 beats per
- •minute (bpm) between screening and Day -1.
- •15. Any clinically significant abnormalities in laboratory test results in this patient
- •population (including hepatic and renal panels, complete blood count, chemistry
- •panel, serology and urinalysis) at screening or Day -1.
- •16. A history of acute clinically significant gastro-intestinal, musculoskeletal,
- •endocrine, hematological, psychiatric, renal, hepatic, bronchopulmonary,
- •neurological disease, acute venous thromboembolism within the last 3 months, a
- •mechanical heart valve, acute stroke, transient ischaemic event (TIA) or acute
- •myocardial infarction.
- •17. Creatinine Clearance of <60 mL/min (as estimated using Cockroft-Gault formula).
- •This may be confirmed by urine creatinine clearance, the results of which will
- •override the Cockroft-Gault estimated results.
- •18. Any other concomitant disease or condition that could interfere with, or for which
- •the treatment of might interfere with, the conduct of the study, or that would, in
- •the opinion of the investigator, pose an unacceptable risk to the subject in this
- •19. Known history of clinically significant allergic hypersensitivity reactions or drug
- •hypersensitivity (non-active hay fever is acceptable), including a known allergy
- •to the study drug or to any of its components.
研究者
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