NCT01515553已完成1 期
A Randomized, Double-blind, Single-centre, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between the Phase 3a Formulation of Liraglutide (Formulation 4) and the Planned Phase 3b Formulation (Final Formulation 4)
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
- 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 the phase 3a formulation of liraglutide (formulation 4) and the liraglutide formulation planned for phase 3b trials (final formulation 4).
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 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) of 18.0-27.0 kg/m^2, both inclusive
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 trial, as judged by the Investigator
- •Impaired renal function
- •Any clinically significant abnormal ECG, as judged by the Investigator
- •Active hepatitis B and/or active hepatitis C
- •Positive human immunodeficiency virus (HIV) antibodies
- •Known or suspected allergy to trial product(s) or related products
- •Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
- •History of alcoholism or drug abuse, or positive results in alcohol or drug screens
- •Smoking of more than 5 cigarettes per day, or the equivalent for other tobacco products
- •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
研究组 & 干预措施
Formulation 4
Experimental
干预措施: liraglutide (Drug)
Final formulation 4
Experimental
干预措施: liraglutide (Drug)
结局指标
主要结局
Cmax, maximum concentration
Area under the curve (0-t)
次要结局
- Terminal elimination half life (t½)
- Time to reach maximum (tmax)
- Area under the curve (0-infinity)
- Relative bioavailability
- Terminal elimination rate constant
- Adverse events
研究者
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