NCT01487811已完成1 期
Bioequivalence of Two Biphasic Insulin Aspart 30 (NovoLog® Mix 70/30) Formulations (Current and New Formulation With Glycerol): A Randomized, Double-Blind, Two-Period Crossover Study in Healthy Volunteers
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
- 50
- 试验地点
- 1
- 主要终点
- Area under the concentration curve (AUC) of the two formulations from time 0 hours to infinity
研究概览
简要总结
This trial is conducted in the United states of America (USA). The aim of this trial is to compare two formulations of biphasic insulin aspart 30 in healthy volunteers.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI (body mass index) between 18 and 28 kg/m^2, both inclusive
- •Subject is a nonsmoker for at least 3 months
- •Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data
- •Fasting plasma glucose between 80 and 110 mg/dl
排除标准
- ••Any clinically significant disease history of systemic or organ disease
- ••Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)
- ••In females of child bearing potential: Pregnancy, lactating, breastfeeding, intent to become pregnant within the next 6-months or judged to be using inadequate contraceptive measures (adequate contraceptive measures include: condom, intrauterine devices). ß-hCG pregnancy test must be negative
研究组 & 干预措施
Formulation 1
Experimental
干预措施: biphasic insulin aspart 30 (Drug)
Formulation 2
Active Comparator
干预措施: biphasic insulin aspart 30 (Drug)
结局指标
主要结局
Area under the concentration curve (AUC) of the two formulations from time 0 hours to infinity
Maximum drug concentration of the two formulations (Cmax)
次要结局
- Area under the concentration curve for insulin aspart from time 0 hours to 16 hours
- Mean residence time (MRT)
- Frequency of adverse events
研究者
研究点 (1)
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