NCT03495739Unknown1 期
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of RDG-17012(Dabigatran Etexilate Tosylate) With Pradaxa® Capsule(Dabigatran Etexilate Mesylate) in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Area Under Curve(AUC) last of Total dabigatran and Free dabigatran
研究概览
简要总结
A randomized, open-label, single-dosing, 2x2 crossover study, the safety and pharmacokinetics of RDG-17012 with Pradaxa® in healthy male volunteers
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 19 to 45, healthy male subjects(at screening)
- •Subject without a hereditary problems, chronic disease and morbid symptom
- •Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress
排除标准
- •Volunteer who has past or present history of any diseases following below.(liver, kidney,digestive system, pulmonary,hematooncology, endocrine, urinary,neurology,mental disorder, skeletomuscular, immunology, otolaryngology,cardiovascular)
- •Exceed 2 times the normal range of AST, ALT, Total Bilirubin at screening test
- •History of drug abuse, or a positive urine drug screen
- •Regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study
- •Any condition that, in the view of the investigator, would interfere with study participation
研究组 & 干预措施
RDG-17012® capsule
Experimental
RDG-17012 ® capsule(dabigatran etexilate tosylate)
干预措施: RDG-17012 Capsule (Drug)
Pradaxa® capsule
Active Comparator
Pradaxa® capsule(dabigatran etexilate mesylate)
干预措施: Dabigatran Etexilate Mesylate 150 MG Oral Capsule (Drug)
结局指标
主要结局
Area Under Curve(AUC) last of Total dabigatran and Free dabigatran
时间窗: (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2
Maximum of concentration(Cmax) of Total dabigatran and Free dabigatran
时间窗: (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2
次要结局
- Area Under Curve(AUC)inf of Total dabigatran and Free dabigatran((Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2)
研究者
研究点 (1)
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