NCT01518166已完成1 期
A Two-way Cross-over, Placebo-controlled Interaction Trial in Two Parts (in Healthy Subjects), Studying Liraglutide's Potential Influence on the Absorption Pharmacokinetics of Lisinopril, Atorvastatin, Griseofulvin and Digoxin, and Liraglutide's Potential Influence on Intragastric pH
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
- 70
- 试验地点
- 1
- 主要终点
- Area under the curve of atorvastatin
研究概览
简要总结
The trial is conducted in Europe. The aim of the trial is to investigate if there is any drug to drug interaction between liraglutide and atorvastatin (Lipitor®), lisinopril (Zestril®), griseofulvin and digoxin (Lanoxin®).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female subjects if using adequate anti-contraception or is sterile
- •Body Mass Index (BMI) of 18-30 kg/m^2 (both inclusive)
- •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
- •Willing and capable to self-administer a subcutaneous injection
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
- •Blood pressure and heart rate in supine position outside the ranges 90-140 mmHg systolic, 50-90 mmHg diastolic and heart rate 40-100 beats/min
- •Any clinically significant abnormal ECG
- •Active hepatitis B and/or active hepatitis C
- •Positive HIV (human immunodeficiency virus) antibodies
- •Known or suspected allergy to trial product(s) or related products
- •Use of any prescription or non-prescription medication except for paracetamol, nasal spray or drops for nasal congestion, and vitamins within 2 weeks prior to first dosing and during the entire trial period
- •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
Trial period A
Experimental
干预措施: liraglutide (Drug)
Trial period A
Experimental
干预措施: placebo (Drug)
Trial period A
Experimental
干预措施: atorvastatin (Drug)
Trial period A
Experimental
干预措施: lisinopril (Drug)
Trial period B
Experimental
干预措施: liraglutide (Drug)
Trial period B
Experimental
干预措施: placebo (Drug)
Trial period B
Experimental
干预措施: griseofulvin (Drug)
Trial period B
Experimental
干预措施: digoxin (Drug)
结局指标
主要结局
Area under the curve of atorvastatin
Area under the curve of lisinopril
Area under the curve of griseofulvin
Area under the curve of digoxin
次要结局
- Cmax, maximum concentration
- Terminal elimination rate constant
- Intragastric pH
- Adverse events
- Area under the curve of liraglutide
- tmax, time to reach Cmax
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Effect of Liraglutide on Absorption of Paracetamol in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT01517555Novo Nordisk A/S18
已完成
1 期
A Trial to Assess the Effect of Liraglutide on Gastric Emptying in Healthy Obese VolunteersMetabolism and Nutrition DisorderObesityNCT00978393Novo Nordisk A/S49
已完成
1 期
Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy VolunteersHealthyDiabetesNCT01707160Novo Nordisk A/S24
已完成
1 期
First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid ArthritisInflammationRheumatoid ArthritisNCT00927927Janssen Research & Development, LLC65
已完成
2 期
A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid ArthritisInflammationRheumatoid ArthritisNCT01223911Novo Nordisk A/S34