NCT02287415已完成1 期
The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin in Healthy Volunteers
Bial - Portela C S.A.0 个研究点目标入组 13 人开始时间: 2002年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 主要终点
- Cmax - Maximum Steady-state Plasma Concentration
研究概览
简要总结
Multiple-dose, open-label, single-period study consisting of three consecutive phases
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 1
Experimental
Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin
干预措施: BIA 2-093 (Drug)
Group 1
Experimental
Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin
干预措施: Warfarin (Drug)
结局指标
主要结局
Cmax - Maximum Steady-state Plasma Concentration
时间窗: PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.
次要结局
- AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h, the Dosing Interval(PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.)
- Tmax - Time of Occurrence of Cmax(PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.)
研究者
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