NCT01530048已完成1 期
A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial, Assessing the Bioequivalence Between Insulin Aspart 100 U/mL and Insulin Aspart 200 U/mL in Healthy Individuals
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
- Cmax, maximum concentration
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to test if there is bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin aspart 200 U/mL (U200) formulation.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Considered to be healthy as judged from vital signs, medical history, ECG (electrocardiogram), laboratory values, and physical examination
- •Body mass index between 18 and 27 kg/m^2 (both inclusive)
- •Non-smoker
- •Fasting blood glucose maximum 6 mmol/L
- •HbA1c below 6.4%
排除标准
- •Pregnant or breast-feeding women
- •Women not using acceptable methods of contraception without difficulties for at least three months prior to trial start (screening), including intrauterine devices, oral contraceptives, hormonal implants, or sterilisation
- •Clinically significant abnormal laboratory values (as judged by the Investigator)
- •Close relative with type 1 diabetes mellitus (father, mother, sister or brother)
- •Intake of alcohol within the last 24 hours prior to screening and drug administration visits
- •Blood donation or blood loss of more than 500 mL within the 3 last months before screening
- •Strenuous exercise within 48 hours before screening as well as drug administration and followup
- •Smoking during the past month before drug administration
研究组 & 干预措施
U200
Experimental
干预措施: insulin aspart (Drug)
U100
Active Comparator
干预措施: insulin aspart (Drug)
结局指标
主要结局
Cmax, maximum concentration
Area under the curve (AUC) in the interval of 0-6 hours
次要结局
- Vz/f, volume of distribution during terminal phase
- GIRmax, maximum glucose infusion rate value
- tGIRmax, time to maximum glucose infusion rate value
- AUC in the interval of 0-infinity hours
- tmax, time to reach Cmax
- Terminal rate constant
- t½, terminal half-life
- AUCGIR, area under the glucose infusion rate value curve
- Adverse events
研究者
研究点 (1)
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