NCT01507337已完成1 期
An Open Label, Single Dose Trial With Two Groups Comparing the Pharmacokinetics of Liraglutide in Young Versus Elderly Healthy Subjects of Both Sexes
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
- 试验地点
- 1
- 主要终点
- Area under the liraglutide plasma concentration time curve (AUC 0-t)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare the exposure of liraglutide in young versus elderly healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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
- •Age, young subjects: age 18-45 years (both incl.)
- •Age, elderly subjects: age at least 65 years
- •Body Mass Index (BMI) 18-30 kg/m^2 (both incl.)
- •Blood pressure, young: Diastolic 50-90 mmHg, systolic 90-140 mmHg
- •Blood pressure, elderly: Diastolic 50-95 mmHg, systolic 92-160 mmHg
排除标准
- •History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease, or other major disorders that could interfere with the objectives of the trial, as judged by the investigator
- •Impaired renal function
- •Any clinically significant abnormal ECG (electrocardiogram)
- •Active hepatitis B and/or active hepatitis C
- •Positive HIV (human immunodeficiency virus) antibodies
- •Febrile illness within 5 days prior to first administration of liraglutide
- •History of alcoholism or drug abuse during the last 12 months
- •Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
- •Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator
研究组 & 干预措施
Elderly
Experimental
干预措施: liraglutide (Drug)
Young
Experimental
干预措施: liraglutide (Drug)
结局指标
主要结局
Area under the liraglutide plasma concentration time curve (AUC 0-t)
次要结局
- Area under the liraglutide plasma concentration time curve (AUC 0-infinity)
- Cmax, maximum liraglutide plasma concentration
- tmax, time to reach Cmax
- t½, terminal plasma elimination half-life
- Adverse events
研究者
研究点 (1)
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