NCT02537405已完成1 期
Randomized, Non-blinded, Two-way Crossover Study to Establish the Bioequivalence Between a Rivaroxaban Tablet 10 mg and a Rivaroxaban Granule 10 mg in Japanese Healthy Adult Male Subjects
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
- Bayer
- 入组人数
- 40
- 主要终点
- Cmax (maximum observed drug concentration in measured matrix after single dose administration)
研究概览
简要总结
The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 10mg and rivaroxaban granule formulation 10mg, and to assess the safety and tolerability of rivaroxaban 10mg in healthy adult male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Japanese healthy male subjects
- •20 to 40 years of age
- •17.6 to 26.4 kg / m² of body mass index (BMI)
排除标准
- •Subject with incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- •Subject with a history of relevant diseases of vital organs, of the central nervous system or other organs, eg instable coronary heart disease, heart failure, liver failure, kidney failure, hypotension, or history of stroke or myocardial infarction
- •Subject with known coagulation disorders (eg von Willebrand's disease, hemophilia)
- •Subject with known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
- •Subject with known sensitivity to common causes of bleeding (eg nasal)
研究组 & 干预措施
BAY59-7939 granule
Experimental
干预措施: Rivaroxaban (BAY 59-7939) (Drug)
BAY59-7939 tablet
Active Comparator
干预措施: Rivaroxaban (Xarelto, BAY 59-7939) (Drug)
结局指标
主要结局
Cmax (maximum observed drug concentration in measured matrix after single dose administration)
时间窗: Multiple time point up to 3 day
AUC(0-tlast) (AUC from time 0 to the last data point > LLOQ (lower limit of quantitation))
时间窗: Multiple time point up to 3 day
次要结局
- Number of participants with adverse events as a measure of safety and tolerability(Up to 30 day)
研究者
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