Non Inferiority Study of a Reduced Dose of Activated Charcoal on Rivaroxaban Pharmacokinetics.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- plasma concentrations of rivaroxaban
研究概览
简要总结
Rivaroxaban is a direct oral anticoagulant that target specifically activated factor X. Bleeding events related to rivaroxaban are the consequence of physiopathologic, pharmacokinetic issues or poisoning. A recent study, in healthy subjects, shows that activated charcoal can reduce significantly exposition to rivaroxaban. However, no results are available on the minimal dose of activated charcoal necessary in rivaroxaban poisoning. The objective of this study is to evaluate the effect of 4 dosing regimen activated charcoal on rivaroxaban pharmacokinetics. It corresponds to a randomised open trial with an incomplete cross over design (3 occasions). It will enrol 12 healthy subjects. Four treatments modalities will be studied: rivaroxaban with 50g, 24g, 12g and 6g of activated charcoal administrated 3 hours after rivaroxaban intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Affiliated or beneficiary of a social security category
- •Having signed the inform consent form
- •Having signed the biologic consent form
- •Men aged between 18 and 40 years
- •Weight between 55 and 92 kilogram
- •normal clinical exam
- •normal biological exam
排除标准
- •Contra-indication to rivaroxaban
- •Contra-indication to activated charcoal
- •With a history of hemorrhagic disease
- •Organic lesion likely to bleed
- •Severe liver disease
- •Severe kidney failure
- •Gastroduodenal ulcers
- •Any medication taken during the week prior to the start of the study
- •Consumption of grapefruit juice
- •Routine ingestion of excessive amounts of coffee, tea, chocolate and/or caffeinated beverages
- •Practice of violent sports
- •Fructose intolerance
- •Glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency syndrome
- •Notable medical history (cardiovascular pathology, pulmonary, neurology ...)
研究组 & 干预措施
Arm A
- Period " rivaroxaban and 6 milligram of activated charcoal "
- Washout period (6 days)
- Period " rivaroxaban and 12 milligram of activated charcoal "
- Washout period (6 days)
- Period " rivaroxaban and 50 milligram of activated charcoal "
- Washout period (6 days)
干预措施: Rivaroxaban (Drug)
Arm A
- Period " rivaroxaban and 6 milligram of activated charcoal "
- Washout period (6 days)
- Period " rivaroxaban and 12 milligram of activated charcoal "
- Washout period (6 days)
- Period " rivaroxaban and 50 milligram of activated charcoal "
- Washout period (6 days)
干预措施: Activated charcoal (Drug)
Arm B
- Period " rivaroxaban and 12 milligram of activated charcoal "
- Washout period (6 days)
- Period " rivaroxaban and 6 milligram of activated charcoal "
- Washout period (6 days)
- Period " rivaroxaban and 24 milligram of activated charcoal "
- Washout period (6 days)
干预措施: Rivaroxaban (Drug)
Arm B
- Period " rivaroxaban and 12 milligram of activated charcoal "
- Washout period (6 days)
- Period " rivaroxaban and 6 milligram of activated charcoal "
- Washout period (6 days)
- Period " rivaroxaban and 24 milligram of activated charcoal "
- Washout period (6 days)
干预措施: Activated charcoal (Drug)
Arm C
- Period " rivaroxaban and 50 milligram of activated charcoal "
- Washout period (6 days)
- Period " rivaroxaban and 24 milligram of activated charcoal "
- Washout period (6 days)
- Period " rivaroxaban and 6 milligram of activated charcoal "
- Washout period (6 days)
干预措施: Rivaroxaban (Drug)
Arm C
- Period " rivaroxaban and 50 milligram of activated charcoal "
- Washout period (6 days)
- Period " rivaroxaban and 24 milligram of activated charcoal "
- Washout period (6 days)
- Period " rivaroxaban and 6 milligram of activated charcoal "
- Washout period (6 days)
干预措施: Activated charcoal (Drug)
Arm D
- Period " rivaroxaban and 24 milligram of activated charcoal "
- Washout period (6 days)
- Period " rivaroxaban and 50 milligram of activated charcoal "
- Washout period (6 days)
- Period " rivaroxaban and 12 milligram of activated charcoal "
- Washout period (6 days)
干预措施: Rivaroxaban (Drug)
Arm D
- Period " rivaroxaban and 24 milligram of activated charcoal "
- Washout period (6 days)
- Period " rivaroxaban and 50 milligram of activated charcoal "
- Washout period (6 days)
- Period " rivaroxaban and 12 milligram of activated charcoal "
- Washout period (6 days)
干预措施: Activated charcoal (Drug)
结局指标
主要结局
plasma concentrations of rivaroxaban
时间窗: 1, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 24 hours after rivaroxaban administration
rivaroxaban pharmacokinetics
次要结局
- Adverse events(24 hour after rivaroxaban administration)