NCT01527565已完成1 期
A Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Area under the insulin aspart curve in the interval from 0-16 hours
研究概览
简要总结
This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male 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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Considered generally healthy upon completion of medical history and physical
- •examination, as judged by the investigator
- •Body Mass Index (BMI) between 19-29 kg/m^2 (both inclusive)
- •Minimum body weight of 65 kg
- •Fasting blood glucose between 3.8-6.0 mmol/L
- •Glycohemoglobin (HbA1c) below 6.4 %
- •Non-smokers
排除标准
- •Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
- •A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject
- •History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen)
- •Hepatitis B or C
- •Subjects with a first-degree relative with diabetes mellitus
- •Known or suspected allergy to trial product or related products
- •Smoking during the past three months
研究组 & 干预措施
Formulation A
Experimental
干预措施: biphasic insulin aspart 70 (Drug)
Formulation B
Experimental
干预措施: biphasic insulin aspart 70 (Drug)
结局指标
主要结局
Area under the insulin aspart curve in the interval from 0-16 hours
Cmax, maximum insulin aspart concentration
次要结局
- tmax, the time to maximum insulin aspart concentration
- Area under the insulin aspart curve
- Mean residence time (MRT)
- The area under the glucose infusion rate curve
- GIRmax, maximum glucose infusion rate value
- tGIRmax, time to maximum glucose infusion rate value
- Adverse events
研究者
研究点 (1)
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