NCT01242826已完成1 期
A Trial Investigating the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 (BIAsp 50) 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
- 主要终点
- Area under the serum insulin aspart concentration-time curve from 0 to 24hours
研究概览
简要总结
This trial is conducted in Asia. The aim of this clinical trial is to investigate the pharmacokinetic properties (the rate at which the trial drug is eliminated from the body) after a single subcutaneous (under the skin) injection of biphasic insulin aspart 50 (BIAsp 50). In addition, the safety and tolerability of BIAsp 50 will be observed
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator (the Physician)
- •Body Mass Index (BMI): 19.0-24.0 kg/m2 (both inclusive)
排除标准
- •Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests, as judged by the Investigator (the Physician)
- •A history of any illness that, in the opinion of the Investigator (the Physician), might confound the results of the trial or a 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 (trial entry)
- •Not able or willing to refrain from smoking during the inpatient period
研究组 & 干预措施
A
Experimental
干预措施: biphasic insulin aspart 50 (Drug)
结局指标
主要结局
Area under the serum insulin aspart concentration-time curve from 0 to 24hours
时间窗: 24 hours profile after single dose of trial drug
次要结局
- Area under the serum insulin aspart concentration-time curve between different time intervals(24 hours profile after single dose of trial drug)
- Maximum observed serum insulin aspart concentration(24 hours profile after single dose of trial drug)
- Number of adverse events.(After 3-10 days of treatment)
- Number of hypoglycaemic events(After 3-10 days of treatment)
研究者
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