NCT01178853已完成4 期
Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Percent Mean Change From Baseline of International Normalized Ratio (INR)
研究概览
简要总结
This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Subject is a healthy adult male or female volunteer aged 18 to 45 years, inclusive
- •Subject has a body mass index of 18 to 32 kg/m2, inclusive
- •Subject is able and willing to abstain from alcohol, grapefruit, caffeine
- •Subject has no clinically relevant abnormalities on the basis of medical history, physical examination, and vital signs
排除标准
- •Subject has clinically relevant out-of-range prothrombin time (PT), activated partial thromboplastin time, fibrinogen, protein C, or protein S
- •Subject has abnormal prolongation of bleeding time at Screening
- •Subject has hematuria on urinalysis
- •Subject has personal or family history of coagulation or bleeding disorders
研究组 & 干预措施
Pitavastatin/Rosuvastatin
Experimental
干预措施: Warfarin (Drug)
Pitavastatin/Rosuvastatin
Experimental
干预措施: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) (Drug)
Pitavastatin/Rosuvastatin
Experimental
干预措施: Warfarin 5 mg + Pitavastatin 4mg once daily (QD) (Drug)
Rosuvastatin/Pitavastatin
Experimental
干预措施: Warfarin (Drug)
Rosuvastatin/Pitavastatin
Experimental
干预措施: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) (Drug)
Rosuvastatin/Pitavastatin
Experimental
干预措施: Warfarin 5 mg + Pitavastatin 4mg once daily (QD) (Drug)
结局指标
主要结局
Percent Mean Change From Baseline of International Normalized Ratio (INR)
时间窗: 22 Days
INR is the ratio of a patient's prothrombin time to a standard, raised to the power of the ISI value for the tissue factor reagent used (INR = (PT-Test/PT-Normal)\^ISI)
次要结局
未报告次要终点
研究者
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