A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 546
- 试验地点
- 3
- 主要终点
- AUC0-24h,semaglutide,SS Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (SS)
研究概览
简要总结
The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of Semaglutide. The study will consist of 3 groups and the treatment the participants will get is dependent on the group the participants will be enrolled in.
The participants in group 1 will receive treatment for 22 weeks, group 2 for 21 weeks and group 3 for 20 weeks.
The study will last up to 29 to 31 weeks for each participant. This includes a screening period (up to 4 weeks), a dose escalation period (up to 2 weeks), a treatment period (20 weeks) and a follow-up period (5 weeks after the last dose).
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
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 21.0 and 32.0 kg/m^2 (both inclusive).
- •Considered to be generally 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
- •HbA1c equal to or greater than 6.5 % (48 mmol/mol) at screening.
- •Use of tobacco and nicotine products, defined as any of the below:
- •Smoking more than 5 cigarettes or the equivalent per day
- •Not willing to refrain from smoking and use of nicotine substitute products within 48 hours prior to and during the inpatient periods
- •Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
- •History(a) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant(a).
- •Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma(a).
- •As declared by the participant or reported in the medical records
研究组 & 干预措施
Group 2 Sequence 2
Crossover arm
干预措施: Semaglutide D Dose 1 (Drug)
Group 3 Sequence 2
Crossover arm
干预措施: Semaglutide D Dose 1 (Drug)
Group 1 Sequence 1
Crossover arm
干预措施: Semaglutide D Dose 1 (Drug)
Group 1 Sequence 1
Crossover arm
干预措施: Semaglutide D Dose 2 (Drug)
Group 1 Sequence 1
Crossover arm
干预措施: Semaglutide D Dose 3 (Drug)
Group 1 Sequence 1
Crossover arm
干预措施: Semaglutide Dose 6 (Drug)
Group 1 Sequence 2
Crossover arm
干预措施: Semaglutide D Dose 3 (Drug)
Group 1 Sequence 2
Crossover arm
干预措施: Semaglutide Dose 4 (Drug)
Group 1 Sequence 2
Crossover arm
干预措施: Semaglutide Dose 5 (Drug)
Group 1 Sequence 2
Crossover arm
干预措施: Semaglutide Dose 6 (Drug)
Group 2 Sequence 1
Crossover arm
干预措施: Semaglutide D Dose 1 (Drug)
Group 2 Sequence 1
Crossover arm
干预措施: Semaglutide D Dose 2 (Drug)
Group 2 Sequence 1
Crossover arm
干预措施: Semaglutide Dose 4 (Drug)
Group 2 Sequence 1
Crossover arm
干预措施: Semaglutide Dose 5 (Drug)
Group 2 Sequence 2
Crossover arm
干预措施: Semaglutide D Dose 2 (Drug)
Group 2 Sequence 2
Crossover arm
干预措施: Semaglutide Dose 4 (Drug)
Group 2 Sequence 2
Crossover arm
干预措施: Semaglutide Dose 5 (Drug)
Group 3 Sequence 1
Crossover arm
干预措施: Semaglutide D Dose 1 (Drug)
Group 3 Sequence 1
Crossover arm
干预措施: Semaglutide Dose 4 (Drug)
Group 3 Sequence 2
Crossover arm
干预措施: Semaglutide Dose 4 (Drug)
结局指标
主要结局
AUC0-24h,semaglutide,SS Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (SS)
时间窗: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
h∙nmol/L
Cmax,0-24h.semaglutide,SS Maximum semaglutide plasma concentration at steady state
时间窗: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
nmol/L
次要结局
- tmax,0-24h,semaglutide,SS Time to maximum semaglutide plasma contraction at steady state(24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.)
- Ctau,24h,semaglutide,SS Semaglutide plasma concentration 24 hours after last dose at steady state(24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.)