NCT01497587已完成1 期
A Single Centre, Open-labelled Trial to Investigate the Pharmacokinetics of Insulin Detemir in Healthy Taiwanese 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 pharmacokinetics of insulin detemir in healthy Taiwanese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Considered generally healthy upon completion of medical history and physical examination as judged by the investigator
- •Body mass index (BMI) between 18 and 27 kg/m^2, inclusive
- •Fasting plasma glucose maximum 6.1 mmol/l
- •Non-smoker or smoking maximum 5 cigarettes per day or the equivalent
排除标准
- •Participation in any other clinical trial involving other investigational products within the last 3 months
- •Subject with a history of alcohol or drug dependence
- •Subject with a first-degree relative with diabetes mellitus
研究组 & 干预措施
Insulin detemir
Experimental
干预措施: insulin detemir (Drug)
结局指标
主要结局
Area under the insulin detemir concentration curve
次要结局
- Maximum insulin detemir concentration
- Time to maximum insulin detemir concentration
- Insulin detemir half-life
- The mean residence time of insulin detemir
研究者
研究点 (1)
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