NCT01513525已完成1 期
A Randomised, Open-label, Single Centre, Three Period Cross-over Trial in Healthy Subjects Comparing the Pharmacokinetic Profiles After Single Dose Administration of Liraglutide at Three Different Injection Sites
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
- 21
- 试验地点
- 1
- 主要终点
- Area under the Curve (AUC) of liraglutide for each injection site
研究概览
简要总结
This trial is conducted in Europe. the aim of this trial is to compare the pharmacokinetic profile of liraglutide between administrations in the thigh versus the abdomen and between administrations in the upper arm versus the abdomen.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Good general health as judged by the Investigator based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments
- •BMI (Body Mass Index): 18.5-27.5 kg/m^2, both inclusive
排除标准
- •Known or suspected allergy to trial product(s) or related products
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods as required by local law or practice
- •The receipt of any investigational drug within 3 months prior to this trial
- •History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator
- •Impaired renal function
- •Active hepatitis B and/or active hepatitis C
- •Positive human immunodeficiency virus (HIV) antibodies
- •Use of any prescription or non-prescription medication, except for paracetamol and vitamins
- •History of alcoholism or drug abuse during the last 12 months.
- •Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the Investigator
- •Excessive consumption of a diet deviating from a normal diet as judged by the Investigator
- •Blood donation within the last 3 months
- •Plasma donation within the last month
研究组 & 干预措施
Abdomen
Experimental
干预措施: liraglutide (Drug)
Thigh
Experimental
干预措施: liraglutide (Drug)
Upper arm
Experimental
干预措施: liraglutide (Drug)
结局指标
主要结局
Area under the Curve (AUC) of liraglutide for each injection site
次要结局
- AUC
- Cmax, maximum concentration
- tmax, time to maximum concentration
- t½, terminal half-life
- Terminal elimination rate constant
- Relative Bioavailability
- Adverse events
研究者
研究点 (1)
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