NCT01623375已完成1 期
A Trial Investigating the Absolute Bioavailability of Insulin Degludec in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Area under the serum insulin degludec concentration-of s.c. administration
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the absolute bioavailability of insulin degludec (IDeg) in healthy subjects.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Considered generally healthy upon completion of medical history, physical examination, analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
- •Body mass index 18.0-27.0 kg/m^2 (both inclusive)
排除标准
- •Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- •Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
- •Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
研究组 & 干预措施
s.c.
Experimental
干预措施: insulin degludec (Drug)
i.v.
Experimental
干预措施: insulin degludec (Drug)
结局指标
主要结局
Area under the serum insulin degludec concentration-of s.c. administration
时间窗: From 0 to infinity after single dose
Area under the serum insulin degludec concentration-of i.v. administration
时间窗: From 0 to infinity after single dose
次要结局
- Terminal half-life for insulin degludec(From 0 to 30 hours after single dose)
- Volume of distribution of insulin degludec, estimated during the terminal phase(From 0 to 30 hours after single dose)
研究者
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