A Randomised, Three-period Crossover Trial in Healthy Subjects Investigating the Relationship Between the Pharmacodynamic Steady State and the Pharmacokinetic Steady State in the Interstitial Fluid Following iv Infusion of Insulin Detemir and Human Insulin Using Microperfusion Technique
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Steady state glucose infusion rate (GIR) / interstitial insulin steady state concentration
研究概览
简要总结
This study is conducted in Europe. The aim of this study is to estimate the relationship between pharmacodynamic and interstitial pharmacokinetic steady state following intravenous (i.v.) administration of insulin detemir and human soluble insulin.
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
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Healthy males between 19 and 50 years inclusive
- •The subject must give signed informed consent before any trial related activity. (Trial related activities are any procedures that would not have been performed during the normal management of the subject)
- •Body Mass Index (BMI) below 27 kg/m^2
- •Fasting blood glucose maximum 6 mmol/l
排除标准
- •Participation in any other clinical trial involving other investigational products within the last 3 months
研究组 & 干预措施
Insulin detemir 60 pmol/kg/min
Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order)
干预措施: insulin detemir (Drug)
Insulin detemir 120 pmol/kg/min
Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order)
干预措施: insulin detemir (Drug)
Human insulin 6 pmol/kg/min
Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order)
干预措施: human soluble insulin (Drug)
结局指标
主要结局
Steady state glucose infusion rate (GIR) / interstitial insulin steady state concentration
时间窗: 8 hours
次要结局
- Steady state glucose infusion rate (GIR)(8 hours)
- Steady state insulin interstitial concentration(8 hours)
- Ratio of steady state serum insulin concentration to interstitial insulin concentration(8 hours)
- Insulin concentration profiles(8 hours)