NCT02844790已完成1 期
A Trial Investigating the Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart in Healthy Chinese 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
- 24
- 试验地点
- 1
- 主要终点
- Area under the serum insulin degludec concentration-time curve
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) properties of insulin degludec/insulin aspart in healthy Chinese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female Chinese subject aged 18-45 years (both inclusive)
- •Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the investigator
- •Body mass index 19.0-24.0 kg/m^2 (both inclusive)
排除标准
- •A history of any illness that, in the opinion of the investigator, might confound the results of the trial or pose risk in administering the trial product to the subject
- •Subject who has donated any blood or plasma in the past month or more than 400 mL within 3 months prior to screening
- •Smoking more than 5 cigarettes (including nicotine substitute products), or the equivalent, per
研究组 & 干预措施
IDegAsp
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
结局指标
主要结局
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
- Maximum observed serum insulin aspart concentration(After single dose (within 0 to 12 hours after dosing))
- Time to maximum observed serum insulin degludec concentration(After single dose (within 0 to 120 hours after dosing))
- Maximum observed serum insulin degludec concentration(After single dose (within 0 to 120 hours after dosing))
- Time to maximum observed serum insulin aspart concentration(After single dose (within 0 to 12 hours after dosing))
研究者
研究点 (1)
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