NCT01620450已完成1 期
A Single-centre, Randomised, Double Blind, Cross-over Trial Demonstrating the Bioequivalence Between NN2000-Mix30 and NN-X14Mix30 (NovoRapid® 30 Mix) in Healthy Japanese 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
- 34
- 试验地点
- 1
- 主要终点
- Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h)
研究概览
简要总结
This trial is conducted in Japan. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process in healthy Japanese 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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Considered generally healthy based on medical history and physical examination
- •Body Mass Index (BMI) between 18 and 27 kg/m^2 (both inclusive)
- •Fasting plasma glucose between 3.8 mmol/L (68.4 mg/dL) and 6.0 mmol/L (108.0 mg/dL)
排除标准
- •Clinically significant abnormal values in clinical laboratory tests of haematology, biochemistry, fasting plasma glucose and urinalysis
- •Any serious systemic infectious disease that occurred during the last 4 weeks before trial
- •Any inter-current illness that may affect blood glucose
- •Subject with a first degree relative with diabetes mellitus
- •Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 4 weeks
研究组 & 干预措施
NN2000
Experimental
干预措施: biphasic human insulin 30 (Drug)
NN-X14
Active Comparator
干预措施: biphasic human insulin 30 (Drug)
结局指标
主要结局
Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h)
时间窗: From 0 to 16 hours after injection
Maximum insulin aspart concentration (Cmax IAsp)
次要结局
- Adverse events
- Terminal elimination half life (t½)
- Area under the curve of insulin aspart concentration (AUC IAsp)
- Time to maximum insulin aspart concentration (tmax IAsp)
- Body weight
研究者
研究点 (1)
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