Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Cmax of fluvoxamine and of digoxin
研究概览
简要总结
The investigators will compare plasma kinetics of two marker drugs in individuals with different genetic variations in the MDR1-gene. The hypothesis is that one group will have higher exposure than the other.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Healthy volunteer ≥ 18 years of age
- •Normal kidney function as measured by GFR according to Cockroft-Gault (70-120 ml/min)
- •Normal P-potassiumvalue (3,6-4,6 mmol/L)
- •HF>50 and no AV-block on resting ECG. No other significant abnormalities as judged by the investigator.
- •Subject giving written informed consent
- •Subject capable of understanding instructions
排除标准
- •- Pregnancy
- •Ongoing infection
- •Intake of medication, including natural remedies (for example St John´s wort), within one month prior to starting study except for paracetamol.
- •Active drug or alcohol abuse
研究组 & 干预措施
2677GG
plasma kinetics of fluvoxamine and digoxin in this genotype
干预措施: fluvoxamine (Drug)
2677GG
plasma kinetics of fluvoxamine and digoxin in this genotype
干预措施: Digoxin (Drug)
2677TT
Plasma kinetics of fluvoxamine and digoxin in this genotype
干预措施: fluvoxamine (Drug)
2677TT
Plasma kinetics of fluvoxamine and digoxin in this genotype
干预措施: Digoxin (Drug)
结局指标
主要结局
Cmax of fluvoxamine and of digoxin
时间窗: 2 days for fluvoxamine and 2 days for digoxin. Washout period of at least 1 week between the both parts. Total study time maximum 4 weeks.
The participants are administered a single dose of fluvoxamine or digoxin. Plasma kinetics of fluvoxamine are followed for 36 hours. Plasma kinetics of digoxin are followed for 48 hours. There is a washout period between the both parts.
次要结局
未报告次要终点
研究者
Erik Sparve
MD, specialist in clinical pharmacology
Karolinska Institutet