Effect of Inhibitors of the Proton Pump on Intestinal Transporters and Their Impact on the Pharmacokinetics of Dabigatran - Mechanistic and Clinical Approach -BIPP Study
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
- Area under the curve (AUC) from plasma concentrations of dabigatran
研究概览
简要总结
Dabigatran etexilate is a novel oral anticoagulant. It is indicated in venous thromboembolic prevention in orthopedic surgery and has recently shown greater efficiency and tolerance as anticoagulants in preventing thromboembolism in atrial fibrillation. However, it increases the risk of gastrointestinal bleeding compared to standard treatment (AVK) [3]. In these circumstances the risk / benefit of dabigatran could be improved by combining it with gastric protectors such as inhibitor drugs proton pump (IPP).
Investigators want to evaluate the pharmacokinetic and pharmacodynamic effects of co-administration of these two IPP (omeprazole, rabeprazole) with dabigatran in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •weight between 60 and 85 kg
- •normal clinical exam
- •normal biological exam
排除标准
- •hypersensitivity to dabigatran or any of its excipients
- •hypersensitivity to omeprazole or rabeprazole or any of its excipients
- •previous history of hemorrhagic disease
- •insufficiency liver
- •severe kidney failure
- •peptic ulcer
- •Any drug taken during the week before the start of the study
- •Consumption of grapefruit juice
- •practice of violent sport
研究组 & 干预措施
Arm A
- Period " Dabigatran"
- Washout period (at least 6 days)
- Period " Rabeprazole + Dabigatran"
- Washout period (at least 6 days)
- Period " Omeprazole + Dabigatran"
干预措施: Dabigatran (Drug)
Arm A
- Period " Dabigatran"
- Washout period (at least 6 days)
- Period " Rabeprazole + Dabigatran"
- Washout period (at least 6 days)
- Period " Omeprazole + Dabigatran"
干预措施: Rabeprazole and Dabigatran (Drug)
Arm A
- Period " Dabigatran"
- Washout period (at least 6 days)
- Period " Rabeprazole + Dabigatran"
- Washout period (at least 6 days)
- Period " Omeprazole + Dabigatran"
干预措施: Omeprazole and Dabigatran (Drug)
Arm B
- Period "Rabeprazole + Dabigatran "
- Washout period (at least 6 days)
- Period " Dabigatran"
- Washout period (at least 6 days)
- Period " Omeprazole + Dabigatran"
干预措施: Dabigatran (Drug)
Arm B
- Period "Rabeprazole + Dabigatran "
- Washout period (at least 6 days)
- Period " Dabigatran"
- Washout period (at least 6 days)
- Period " Omeprazole + Dabigatran"
干预措施: Rabeprazole and Dabigatran (Drug)
Arm B
- Period "Rabeprazole + Dabigatran "
- Washout period (at least 6 days)
- Period " Dabigatran"
- Washout period (at least 6 days)
- Period " Omeprazole + Dabigatran"
干预措施: Omeprazole and Dabigatran (Drug)
Arm C
- Period " Rabeprazole + Dabigatran"
- Period " Omeprazole + Dabigatran"
- Period " Dabigatran"
干预措施: Dabigatran (Drug)
Arm C
- Period " Rabeprazole + Dabigatran"
- Period " Omeprazole + Dabigatran"
- Period " Dabigatran"
干预措施: Rabeprazole and Dabigatran (Drug)
Arm C
- Period " Rabeprazole + Dabigatran"
- Period " Omeprazole + Dabigatran"
- Period " Dabigatran"
干预措施: Omeprazole and Dabigatran (Drug)
结局指标
主要结局
Area under the curve (AUC) from plasma concentrations of dabigatran
时间窗: 24 hours after each dose of dabigatran etexilate.
次要结局
未报告次要终点