NCT01515579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 2 Formulation of Liraglutide at pH 7.7 (Formulation 3) and the Phase 3 Formulation at pH 8.15 (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
- Area under the curve (0-t)
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 at pH 8.15 (formulation 4) and liraglutide at pH 7.7 (formulation 3).
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
- •Use of any prescription or non-prescription medication, except for paracetamol and vitamins, as judged by the Investigator
研究组 & 干预措施
Formulation 4
Experimental
干预措施: liraglutide (Drug)
Formulation 3
Experimental
干预措施: liraglutide (Drug)
结局指标
主要结局
Area under the curve (0-t)
Cmax, maximum concentration
次要结局
- Area under the curve
- tmax, time to reach Cmax
- t½, terminal half-life
- Terminal elimination rate constant
- Adverse events
研究者
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