NCT01498939已完成1 期
A Single Centre, Randomised, Double-blind, Three-period Cross-over Trial to Investigate the 24-hour Pharmacokinetics After Single Dose of Insulin Detemir in Healthy Chinese Male 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 insulin detemir concentration curve
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetics after a single dose of insulin detemir in healthy Chinese male 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) between 18 and 25 kg/m^2 (both inclusive)
- •Fasting plasma glucose maximum 6 mmol/L
- •Non-smoker
- •Considered generally healthy upon completion of medical history, physical examination and laboratory assessments, as judged by the Investigator
排除标准
- •Known or suspected allergy to trial product(s) or related products
- •Previous participation in this trial. Participation is defined as randomisation
- •Receipt of any investigational drug within the last three months prior to this trial
- •History of alcohol or drug abuse
研究组 & 干预措施
IDet 0.2 U/kg
Experimental
干预措施: insulin detemir (Drug)
IDet 0.4 U/kg
Experimental
干预措施: insulin detemir (Drug)
IDet 0.8 U/kg
Experimental
干预措施: insulin detemir (Drug)
结局指标
主要结局
Area under the insulin detemir concentration curve
时间窗: from time zero to 24 hour
次要结局
- Insulin detemir clearance
- Terminal half-life
- Area under the insulin detemir concentration curve
- Maximum serum insulin detemir concentration
- Time to maximum serum insulin detemir concentration
- Mean residence time (MRT)
- Adverse events
研究者
研究点 (1)
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