NCT01486914已完成1 期
A Single Centre, Randomized, Balanced Double Blind, Cross-Over Trial Investigating the Bioequivalence of NovoRapid® Produced by the Current Process and Insulin Aspart With the Same Formulation as NovoRapid®, Produced by the NN2000 Process
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
- 28
- 试验地点
- 1
- 主要终点
- Area under the Curve (AUC) (insulin aspart)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Caucasian
- •Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
- •Fasting blood glucose below or equal to 6 mmol/L
- •Body mass index (BMI) 22.0-27.0 kg/m^2 (both inclusive)
排除标准
- •Participated in another clinical study with an investigational drug within the last 4 weeks
- •Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable
- •Known or suspected allergy to the trial product or related products
- •Family history of type 2 diabetes
研究组 & 干预措施
IAsp
Active Comparator
干预措施: insulin aspart (Drug)
NN2000
Experimental
干预措施: insulin aspart (Drug)
结局指标
主要结局
Area under the Curve (AUC) (insulin aspart)
次要结局
- Terminal half life (t½)
- Cmax (maximum plasma concentration)
- Adverse events
- Incident of hypoglycaemic episodes
研究者
研究点 (1)
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