NCT02304627已完成1 期
Effect of Food on the Pharmacokinetics of NNC0123-0000-0338 in a Tablet Formulation 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
- 45
- 试验地点
- 1
- 主要终点
- Area under the serum insulin 338 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 NNC0123-0000-0338 in a tablet formulation in healthy subjects.
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
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-64 years (both inclusive) at the time of signing informed consent
- •Body mass index 18.5-28.0 kg/m^2 (both inclusive)
- •Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
排除标准
- •Known or suspected hypersensitivity to trial products or related products
- •Previous participation in this trial. Participation is defined as informed consent
- •Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to first dosing, as judged by the investigator
研究组 & 干预措施
Eating meal immediately after dosing
Experimental
干预措施: insulin 338 (GIPET I) (Drug)
Eating meal 30 min after dosing
Experimental
干预措施: insulin 338 (GIPET I) (Drug)
Eating meal 1 hour after dosing
Experimental
干预措施: insulin 338 (GIPET I) (Drug)
Eating meal 6 hour after dosing
Experimental
干预措施: insulin 338 (GIPET I) (Drug)
结局指标
主要结局
Area under the serum insulin 338 concentration-time curve
时间窗: From a 0-288 hours NNC0123-0000-0338 serum concentration-time-curve based on 41 sampling time points
次要结局
- Area under the serum insulin 338 concentration-time curve(From 0 to 288 hours after a single dose (SD))
- Maximum observed serum insulin 338 concentration(From 0 to 288 hours after a single dose (SD))
- Area under the plasma capric acid concentration-time curve(From 0 to 24 hours after a single dose)
- Maximum observed plasma capric acid concentration(From 0 to 24 hours after a single dose)
研究者
研究点 (1)
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