NCT01520831已完成1 期
A Randomised, Four-period Cross-over Trial in Healthy Subjects, Investigating the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Soluble Insulin Aspart
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
- 35
- 试验地点
- 1
- 主要终点
- Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart 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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index between 18 and 28 kg/m^2 inclusive
- •HbA1c within the normal laboratory range
- •Non smoker for at least three months
- •Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD) , the oral contraceptive pill or barrier methods
排除标准
- •Subjects who have received any investigational drug in the 3 months prior to the start of dosing
- •Any disease requiring regular use of non topical prescription medicines
- •Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
- •Any intercurrent illness or endocrine disorders that may affect blood glucose
- •Subject with a history of drug or alcohol dependence
- •Subject with a first degree relative with diabetes mellitus
- •Subject with a history of clinically relevant allergic reactions to medical products
- •Subjects who have donated any blood or plasma in the past 3 month preceding screening
研究组 & 干预措施
BIAsp 30
Experimental
干预措施: biphasic insulin aspart 30 (Drug)
BIAsp 50
Experimental
干预措施: biphasic insulin aspart 50 (Drug)
BIAsp 70
Experimental
干预措施: biphasic insulin aspart 70 (Drug)
Insulin aspart
Active Comparator
干预措施: insulin aspart (Drug)
结局指标
主要结局
Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes
次要结局
- t½, terminal half-life
- Area under the GIR profile
- Maximum GIR value
- Time to maximum GIR value
- Cmax, maximum insulin aspart concentration
- Area under the insulin aspart concentration curve
- tmax, the time to maximum insulin aspart concentration
研究者
研究点 (1)
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