NCT01151072已完成1 期
A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties of NN1250 After Different Routes of Administration 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
- 20
- 试验地点
- 1
- 主要终点
- Area under the serum Insulin Degludec concentration-time curve (only for subcutaneous administration)
研究概览
简要总结
This trial was conducted in Europe. The aim of this clinical trial was to compare the exposure and effect of NN1250 (insulin degludec) after different routes of injection 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, 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
IDeg i.m. thigh
Experimental
干预措施: insulin degludec (Drug)
IDeg i.v.
Experimental
干预措施: insulin degludec (Drug)
IDeg s.c. abdomen
Experimental
干预措施: insulin degludec (Drug)
IDeg s.c. deltoid
Experimental
干预措施: insulin degludec (Drug)
IDeg s.c. thigh
Experimental
干预措施: insulin degludec (Drug)
结局指标
主要结局
Area under the serum Insulin Degludec concentration-time curve (only for subcutaneous administration)
时间窗: From 0 to 120 hours after single-dose
次要结局
- Area under the serum Insulin Degludec concentration-time curve (only for intravenous administration)(From 0 to 30 hours after single-dose)
- Maximum observed serum Insulin Degludec concentration after single-dose (only for subcutaneous and intramuscular administration)(Within 0 to 120 hours after dosing)
- Area under the serum Insulin Degludec concentration-time curve (only for intramuscular administration)(From 0 to 120 hours after single-dose)
- Back-extrapolated initial serum Insulin Degludec concentration after single-dose (only for intravenous administration)(At time zero after dosing)
研究者
研究点 (1)
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