NCT01514487已完成1 期
A Randomised, Double-blind, Single-centre, Three-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Each of the Two New Liraglutide Formulations at pH 7.9 and 8.15 and the Planned Phase 3 Formulation at pH 7.7
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
- 24
- 试验地点
- 1
- 主要终点
- Area under the Curve (0-t)
研究概览
简要总结
This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase 3 formulation at pH 7.7.
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
- •Healthy subjects
- •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, 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 study, as judged by the investigator
- •Family or personal history of Primary hyperparathyroidism or pheochromocytoma or thyroid malignancy or multiple endocrine neoplasia
- •Impaired renal function
- •Uncontrolled treated/untreated hypertension
- •Any clinically significant abnormal ECG
- •Active hepatitis B and/or active hepatitis C
- •Positive HIV (human immunideficiency virus) 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
- •Prescription or non-prescription medication, except for paracetamol and vitamins
- •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
pH 7.7
Experimental
干预措施: liraglutide (Drug)
pH 7.9
Experimental
干预措施: liraglutide (Drug)
pH 8.15
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 (0-infinity)
- tmax, time to reach Cmax
- t½, terminal half-life
- Terminal elimination rate constant
- Adverse events
研究者
研究点 (1)
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