NCT01508858已完成1 期
A Double-blind, Two Period Cross-over, Single Centre Trial in Healthy Subjects Investigating the Influence on the Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Drug After Multiple Dose Administration of Liraglutide
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
- 21
- 试验地点
- 1
- 主要终点
- AUC of ethinylestradiol
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide changes AUC (area under the curve) of ethinylestradiol and levonorgestrel administered as a combination contraceptive drug (Neovletta®).
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 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal woman
- •Body Mass Index (BMI) between 18.0-30.0 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, blood and urinary laboratory assessments
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
- •Active hepatitis B and/or active hepatitis C
- •Positive HIV (human immunodeficiency virus) antibodies
- •Known or suspected allergy to trial products or related products
- •Pregnant or positive pregnancy test at screening or nursing mother
- •Use of prescription or non-prescription medication within 2 weeks prior to first dosing with trial products which in the Investigators opinion will interfere with the pharmacokinetics of the compounds in Neovletta®
- •Use of hormone replacement therapy within 4 weeks prior to starting dosing with trial product
- •History of alcoholism or drug abuse
- •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
Treatment period 1
Experimental
干预措施: liraglutide (Drug)
Treatment period 1
Experimental
干预措施: placebo (Drug)
Treatment period 1
Experimental
干预措施: levonorgestrel / ethinylestradiol (Drug)
Treatment period 2
Placebo Comparator
干预措施: liraglutide (Drug)
Treatment period 2
Placebo Comparator
干预措施: placebo (Drug)
Treatment period 2
Placebo Comparator
干预措施: levonorgestrel / ethinylestradiol (Drug)
结局指标
主要结局
AUC of ethinylestradiol
AUC of levonorgestrel
次要结局
- tmax, time to reach Cmax
- Cmax, maximum concentration
- Adverse events
- t½, terminal half-life
- AUC (0-t)
研究者
研究点 (1)
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