NCT01508897已完成1 期
A Randomized, Single-blind, Single-centre, Two-period, Cross-over Trial Investigating the Bioequivalence Between Completed Phase 2 and Planned Phase 3 Formulations of Liraglutide in Healthy Subjects
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
- 22
- 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 for bioequivalence of two formulations of liraglutide.
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
- Single (Participant)
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
- •Body Mass Index (BMI) of 18-27 kg/m^2 incl.
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 may interfere with the objectives of the study, as judged by the investigator
- •Impaired renal function
- •Uncontrolled treated/untreated hypertension
- •Any clinically significant abnormal ECG
- •Active hepatitis B and/or active hepatitis C
- •Positive HIV (human immunodeficiency virus) antibodies
- •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
- •Excessive consumption of a diet deviating from a normal diet as judged by the Investigator
研究组 & 干预措施
Phase 2 formulation
Experimental
干预措施: liraglutide (Drug)
Phase 3 formulation
Experimental
干预措施: liraglutide (Drug)
结局指标
主要结局
Cmax, maximum concentration
Area under the Curve (AUC) (0-t)
次要结局
- Adverse events
- AUC (0-infinity)
- t½, terminal half-life
- tmax, time to maximum concentration
- Terminal elimination rate constant
研究者
研究点 (1)
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