NCT03010475已完成1 期
A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects.
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
- 41
- 试验地点
- 1
- 主要终点
- Area under the furosemide plasma concentration-time curve
研究概览
简要总结
This trial is conducted in Europe. Tha aim of this trial is to investigate the effect of oral semaglutide on the pharmacokinetics of furosemide and rosuvastatin in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
- •Body mass index (BMI) between 20.0-29.9 kg/m^2 (both inclusive)
- •Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiography and clinical laboratory tests performed during the screening visit, as judged by the investigator
排除标准
- •Smoker (defined as a subject who is smoking at least one cigarette or the equivalent per day)
- •Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
- •History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
- •Have personal or family history of myopathy
- •Previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate
- •Thyroid-Stimulating Hormone outside lower limit of normal minus 10 percent and upper limit of normal plus 10 percent
- •Creatine kinase above 5 x upper limit of normal
- •Asian subject
研究组 & 干预措施
Furosemide/Rosuvastatin/SNAC/Semaglutide
Experimental
干预措施: Furosemide (Drug)
Furosemide/Rosuvastatin/SNAC/Semaglutide
Experimental
干预措施: Rosuvastatin (Drug)
Furosemide/Rosuvastatin/SNAC/Semaglutide
Experimental
干预措施: SNAC (Drug)
Furosemide/Rosuvastatin/SNAC/Semaglutide
Experimental
干预措施: Semaglutide (Drug)
结局指标
主要结局
Area under the furosemide plasma concentration-time curve
时间窗: day 1, day 7, day 54
Based on sampling between 0 and 12 hours
Area under the rosuvastatin plasma concentration-time curve
时间窗: day 2, day 8, day 55
Based on sampling between 0 and 96 hours
次要结局
- Maximum observed furosemide plasma concentration(day 1, day 7, day 54)
- Maximum observed rosuvastatin plasma concentration(day 2, day 8, day 55)
研究者
研究点 (1)
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