NCT01511159已完成1 期
A Single-Centre, Open-Label, Five-Period Crossover Trial In Healthy Male Volunteers Investigating the Relative Bioavailability of NNC 90-1170 By Pulmonary Administration Compared To A Subcutaneous Injection
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
- 32
- 主要终点
- Ratio of the areas under the plasma NN 90-1170 curves
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to determine the relative bioavailability of NNC 90-1170 (liraglutide) when inhaled compared to NNC 90-1170 when injected under the skin.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •No clinically important abnormal physical findings
- •No clinically relevant abnormalities in the results of laboratory screening evaluation
- •Normal (or abnormal but not clinically significant) ECG (electrocardiogram)
- •Normal (or abnormal but not clinically significant) blood pressure and heart rate
- •Body Mass Index (BMI) between 20-30 kg/m^2 or outwith range but not clinically significant
- •Non-smoker
- •Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) at least 85% of predicted normal for age, gender and height
- •FVC ratio at least 75% of predicted normal for age, gender and height
排除标准
- •A clinically significant illness or infection requiring treatment within the last two months
- •Any infection involving the respiratory system or adverse event that may, in the opinion of the principal investigator, interfere with blood glucose homeostasis
- •Subjects with first and/or second degree relative(s) with diabetes mellitus
- •Donation or loss of greater than 500 ml of blood in the period 0-12 weeks before trial entry
- •Alcohol use in excess of 28 units of alcohol per week. A unit of alcohol is equivalent to half a pint of average strength beer, a glass (125 ml) of wine or a pub measure (25 ml) of spirits, sherry or port
- •Current addiction to alcohol or substances of abuse
- •Presence of hepatitis B surface antigen, hepatitis C antibody or HIV (human immunodeficiency virus) 1 or 2 antibodies
研究组 & 干预措施
NNC 90-1170, initial dose
Experimental
干预措施: liraglutide (Drug)
NNC 90-1170, initial dose
Experimental
干预措施: placebo (Drug)
NNC 90-1170
Experimental
干预措施: liraglutide (Drug)
Insulin
Active Comparator
干预措施: insulin human (Drug)
NNC 90-1170, final dose
Experimental
干预措施: liraglutide (Drug)
结局指标
主要结局
Ratio of the areas under the plasma NN 90-1170 curves
次要结局
- Area under the curve
- Terminal rate constant
- Mean residence time (MRT)
- The time to maximum concentration (tmax)
- Adverse events
- The maximum concentration (Cmax)
研究者
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