NCT02172313已完成1 期
Effect of Food on the Pharmacokinetics of Oral Semaglutide 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
- 78
- 主要终点
- Area under the semaglutide plasma concentration time curve
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide, in a SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) tablet formulation with three different dosing conditions in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 subject aged 18-75 years (both inclusive) at the time of signing informed consent
- •Body mass index of 18.5-29.9 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 of oral semaglutide. 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, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
- •Not able or not willing to refrain from smoking or use of nicotine substitute products when staying at the clinical unit
- •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
- •Previous gastrointestinal surgery such as invasive and corrective procedures involving the oesophagus, stomach, duodenum, gallbladder, pancreas or intestinal resections. Exempt are subjects that underwent uncomplicated surgical and diagnostic procedures such as appendectomy, hernia surgery, polypectomy, biopsies, as wells as colonic- and gastric endoscopy
研究组 & 干预措施
Fed conditions
Experimental
Fasting for 10 hours overnight followed by a high-fat, high-calorie meal, after the meal dosing of the tablet with 240 mL of water and a post-dose fasting period of 4 hours
干预措施: semaglutide (Drug)
Fasting conditions
Experimental
Fasting for 10 hours overnight followed by dosing of the tablet with 240 mL of water and a post-dose fasting period of 4 hours
干预措施: semaglutide (Drug)
Reference dosing condition
Experimental
Fasting for 6 hours overnight followed by dosing of the tablet with 120 mL of water and a post-dose fasting period of 30 min
干预措施: semaglutide (Drug)
结局指标
主要结局
Area under the semaglutide plasma concentration time curve
时间窗: From time 0 to 24 hours after the 10th daily dose
次要结局
- Terminal half-life of semaglutide(After the 10th daily dose)
- Area under the SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) plasma concentration time curve(From time 0 to 24 hours after the 10th daily dose)
- Time to maximum observed semaglutide plasma concentration(0 to 24 hours after the 10th daily dose)
- Maximum observed semaglutide plasma concentration(0 to 24 hours after the 10th daily dose)
研究者
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