The Effect of Dipyridamole on the Pharmacokinetics of Metformin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The area under the curve of the metformin plasma concentration at several timepoints
研究概览
简要总结
The antihyperglycemic drug metformin and the thrombocyte aggregation inhibitor dipyridamole are often used concomitantly in patients with diabetes who have suffered a transient ischemic attack or stroke. It has recently been suggested that the gastrointestinal absorption of metformin is mediated by the equilibrative nucleoside transporter 4 (hENT4). Dipyridamole has been reported to inhibit hENT4 transport in vitro. The aim of this research proposal is to study the pharmacokinetic interaction between metformin and dipyridamole. The investigators hypothesize that dipyridamole reduces the gastrointestinal absorption of metformin. If this hypothesis can be confirmed, then the results of this study can explain in part the high variability in plasma metformin concentrations in patients treated with diabetes, and can be used to optimize pharmacotherapy in patients with diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-50 years
- •Written informed consent
排除标准
- •Hypertension (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg)
- •Diabetes Mellitus (fasting glucose >7.0 mmol/L or random glucose >11 mmol/L)
- •History of any cardiovascular disease
- •Concomitant use of medication
- •Renal dysfunction (MDRD <60 ml/min)
- •ECG abnormalities, other than firs grade AV-block or right bundle branch block
研究组 & 干预措施
Metformin therapy with concomitant use of dipyridamole
Metformin 500 mg twice daily for four days in combination with dipyridamole 200 mg twice daily for four days
干预措施: Metformin, dipyridamole (Drug)
Metformin therapy
Metformin 500 mg twice daily for four days
干预措施: Metformin (Drug)
结局指标
主要结局
The area under the curve of the metformin plasma concentration at several timepoints
时间窗: 10 hours after ingestion of last dose of metformin
The area under the curve of the metformin plasma concentration at t=0, t=1, t=2, t=2.5, t=3, t=3.5, t=4, t=5, t=6, t=8, and t=10 hours after the intake and the Cmax.
Peak plasma concentration (Cmax) of metformin
时间窗: about 3 hours after intake of last dose of metformin
Peak plasma concentration (Cmax) of metformin
次要结局
未报告次要终点