A Trial Investigating the Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in a Tablet Formulation With Three Different Coatings in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 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 pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0123-0000-0338 (insulin 338) in a tablet formulation with three different coatings 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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index 18.0-28.0 kg/m^2 (both inclusive)
- •Subject who is considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG (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 gastro-intestinal 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
Coating A
Each subject will in random order be allocated to three single-dose administrations of insulin 338 in a GIPET® I tablet with 3 different coatings, respectively, on three separate dosing visits (Visits 2, 3 and 4). Each of the three dosing days will be separated by a 3-week wash-out period (ranging from 20 to 28 days)
干预措施: insulin 338 (GIPET I) (Drug)
Coating B
Each subject will in random order be allocated to three single-dose administrations of insulin 338 in a GIPET® I tablet with 3 different coatings, respectively, on three separate dosing visits (Visits 2, 3 and 4). Each of the three dosing days will be separated by a 3-week wash-out period (ranging from 20 to 28 days)
干预措施: insulin 338 (GIPET I) (Drug)
Coating C
Each subject will in random order be allocated to three single-dose administrations of insulin 338 in a GIPET® I tablet with 3 different coatings, respectively, on three separate dosing visits (Visits 2, 3 and 4). Each of the three dosing days will be separated by a 3-week wash-out period (ranging from 20 to 28 days)
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 dosing to infinity calculated from a 0-288 hours NNC0123-0000-0338 serum concentration-time-curve based on 38 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))
- Area under the glucose infusion rate (GIR)-time curve(From 0 to 24 hours after a single dose)
- Number of treatment emergent adverse events(As recorded from trial product administration (Day 1) at Sub-visit A and until Sub-visit G (Day 13))