NCT02249910已完成1 期
An Open-label, Single Arm, Sequential, Single Centre Trial Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Metformin and Digoxin 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
- 32
- 试验地点
- 1
- 主要终点
- Area under the metformin plasma concentration-time curve
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the influence of oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of metformin and digoxin in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, age 18-75 years (both inclusive) at the time of signing inform consent
- •Body mass index (BMI) 20.0-29.9 kg/m^2 (both inclusive)
- •A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose. Only highly effective methods of birth control are accepted (i.e., one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices)
- •History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
- •Hypertension (defined as sitting systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg). If white-coat hypertension is suspected at the screening visit a repeated measurement is allowed
- •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
研究组 & 干预措施
Semaglutide
Experimental
干预措施: semaglutide (Drug)
Semaglutide
Experimental
干预措施: metformin (Drug)
Semaglutide
Experimental
干预措施: digoxin (Drug)
Semaglutide
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Area under the metformin plasma concentration-time curve
时间窗: During a dosing interval (0 to12 hours) at steady state
Area under the digoxin plasma concentration-time curve
时间窗: From time 0 to infinity after single dose
次要结局
- Maximum observed metformin plasma concentration(During a dosing interval (0 to 12 hours) at steady state)
- Maximum observed digoxin plasma concentration(0 to 120 hours after single dose)
- Maximum observed semaglutide plasma concentration(During a dosing interval (0 to 24 hours) at steady state)
- Area under the SNAC plasma concentration-time curve(During a dosing interval (0 to 24 hours) at steady state)
- Number of hypoglycaemic episodes(From the first dosing (Day 1) and until completion of the post treatment follow up visit (Day 118-122))
研究者
研究点 (1)
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