NCT01125553已完成1 期
A Trial to Test for Bioequivalence Between Two NN5401 Formulations 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
- 26
- 试验地点
- 1
- 主要终点
- Maximum observed serum insulin degludec concentration
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of the trial is to compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) 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
- Double (Participant, Investigator)
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 electrocardiogram (ECG), as judged by the physician
- •Body mass index between 18.0 and 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 trial start
- •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
IDegAsp B
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
IDegAsp F
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
结局指标
主要结局
Maximum observed serum insulin degludec concentration
时间窗: from 0 to 120 hours after single-dose
Maximum observed serum insulin aspart concentration
时间窗: from 0 to 12 hours after single-dose
Area under the serum insulin degludec concentration-time curve
时间窗: from 0 to 120 hours after single-dose
Area under the serum insulin aspart concentration-time curve
时间窗: from 0 to 12 hours after single-dose
次要结局
- Time to maximum observed serum insulin degludec concentration(from 0 to 120 hours after single-dose)
- Time to maximum observed serum insulin aspart concentration(from 0 to 12 hours after single-dose)
研究者
研究点 (1)
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