EUCTR2013-001720-19-DE进行中（未招募）不适用
Single-dose, open-label, randomized, 4-way crossover study to compare 10 mg of an oral suspension of rivaroxaban under fasting (2 different batches) and 20 mg of an oral suspension of rivaroxaban under fed conditions to 10 mg of an immediate release tablet under fasting conditions in healthy male subjects
适应症
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
- Male
入选标准
- •Healthy male subjects
- •Age: 18 to 55 years (inclusive) at the first screening examination
- •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 14
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
- •Known coagulation disorders (eg von Willebrand's disease, hemophilia)
- •Known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
- •Known sensitivity to common causes of bleeding (eg nasal)
- •Regular use of medicines
- •Clinically relevant findings in the ECG such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QTc-interval over 450 msec
- •Clinically relevant findings in the physical examination
- •Clinically relevant deviations of the screened laboratory parameters from reference ranges
- •Participation in another clinical study during the preceding 3 months (Last Treatment from previous study to First Treatment of new study)
研究者
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