NCT01523041已完成1 期
A Randomised, Double Blind, Single Centre, Three Period Crossover Trial Testing the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 and Characterising the Pharmacokinetics of Biphasic Insulin Aspart 50 in Healthy Male 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
- 试验地点
- 1
- 主要终点
- Area under the insulin aspart curve in the interval from 0-24 hours
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare two formulations of biphasic insulin aspart 70 and characterise the pharmacokinetics of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy male subjects.
详细描述
Each subject participated in three treatment periods, and were randomly assigned to each of the six treatment sequences in varying order
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
- •Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
- •Body mass index (BMI) between 19-27 kg/m^2
- •Fasting plasma glucose between 3.8-6.0 mmol/L
排除标准
- •Participation in any other clinical trial involving other investigational products within the last three months
- •Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
- •Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
研究组 & 干预措施
BIAsp 70 clinical trial formulation
Experimental
干预措施: biphasic insulin aspart 70 (Drug)
BIAsp 70 final formulation
Experimental
干预措施: biphasic insulin aspart 70 (Drug)
BIAsp 50 final formulation
Experimental
干预措施: biphasic insulin aspart 50 (Drug)
结局指标
主要结局
Area under the insulin aspart curve in the interval from 0-24 hours
次要结局
- t½, terminal half-life
- Cmin, minimum glucose concentration
- tmin, time to minimum concentration
- Cmax, maximum insulin aspart concentration
- tmax, the time to maximum insulin aspart concentration
研究者
研究点 (1)
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