NCT01448070已完成1 期
A Single Centre, Randomized, Balanced Double Blind, Cross-over Trial Investigating the Bioequivalence of Actrapid® Produced by the Current Process and Human Insulin With the Same Formulation as Actrapid®, Produced by the NN729 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
- AUC (area under the curve) 0-8h (human insulin)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®.
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
- 是
入选标准
- •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 1 diabetes
研究组 & 干预措施
Current manufacturing process
Active Comparator
干预措施: human insulin (Drug)
NN729 manufacturing process
Experimental
干预措施: human insulin (Drug)
结局指标
主要结局
AUC (area under the curve) 0-8h (human insulin)
Cmax (maximum plasma concentration)
Area under the curve (glucose infusion rate (GIR)), 0-8h
次要结局
- tmax (time to reach maximum)
- t½ (terminal half-life)
- GIR (glucose infusion rate) max
- tGIR (glucose infusion rate) max
- Area under the curve (C-peptide, 0-8h)
- Physical examinations and vital signs
研究者
研究点 (1)
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