A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of Semaglutide to Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Adjusted AUC(sema); adjusted area under the semaglutide plasma concentration-time curve
研究概览
简要总结
This study is conducted to compare four different tablets containing the investigational medicine semaglutide at the same dose. It is done to test how semaglutide in each of the tablet versions is taken up in the body. Which treatments participants will receive is decided by chance. The study will last for about 28 weeks. The study will enroll healthy male participants.
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 the informed consent.
- •Body mass index (BMI) between 22.0 and 31.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
- •Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
排除标准
- •Known or suspected hypersensitivity to study interventions or related products.
- •Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen, within 14 days prior to first dosing.
研究组 & 干预措施
Sequence 1: Semaglutide J then Semaglutide L
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide L in treatment period 2.
干预措施: Semaglutide B (Drug)
Sequence 1: Semaglutide J then Semaglutide L
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide L in treatment period 2.
干预措施: Semaglutide J (Drug)
Sequence 1: Semaglutide J then Semaglutide L
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide L in treatment period 2.
干预措施: Semaglutide L (Drug)
Sequence 2: Semaglutide L then Semaglutide J
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide L then semaglutide J in treatment period 2.
干预措施: Semaglutide B (Drug)
Sequence 2: Semaglutide L then Semaglutide J
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide L then semaglutide J in treatment period 2.
干预措施: Semaglutide J (Drug)
Sequence 2: Semaglutide L then Semaglutide J
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide L then semaglutide J in treatment period 2.
干预措施: Semaglutide L (Drug)
Sequence 3: Semaglutide J then Semaglutide M
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide M in treatment period 2.
干预措施: Semaglutide B (Drug)
Sequence 3: Semaglutide J then Semaglutide M
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide M in treatment period 2.
干预措施: Semaglutide J (Drug)
Sequence 3: Semaglutide J then Semaglutide M
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide M in treatment period 2.
干预措施: Semaglutide M (Drug)
Sequence 4: Semaglutide M then Semaglutide J
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide M then semaglutide J in treatment period 2.
干预措施: Semaglutide B (Drug)
Sequence 4: Semaglutide M then Semaglutide J
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide M then semaglutide J in treatment period 2.
干预措施: Semaglutide J (Drug)
Sequence 4: Semaglutide M then Semaglutide J
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide M then semaglutide J in treatment period 2.
干预措施: Semaglutide M (Drug)
Sequence 5: Semaglutide J then Semaglutide N
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide N in treatment period 2.
干预措施: Semaglutide B (Drug)
Sequence 5: Semaglutide J then Semaglutide N
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide N in treatment period 2.
干预措施: Semaglutide J (Drug)
Sequence 5: Semaglutide J then Semaglutide N
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide N in treatment period 2.
干预措施: Semaglutide N (Drug)
Sequence 6: Semaglutide N then Semaglutide J
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide N then semaglutide J in treatment period 2.
干预措施: Semaglutide B (Drug)
Sequence 6: Semaglutide N then Semaglutide J
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide N then semaglutide J in treatment period 2.
干预措施: Semaglutide J (Drug)
Sequence 6: Semaglutide N then Semaglutide J
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide N then semaglutide J in treatment period 2.
干预措施: Semaglutide N (Drug)
结局指标
主要结局
Adjusted AUC(sema); adjusted area under the semaglutide plasma concentration-time curve
时间窗: From 0 to 24 hours after dosing on Days 122 and 132.
Measured in hours nanomoles per liter (h \* nmol/L).
Adjusted Cmax,(sema); adjusted maximum observed semaglutide plasma concentration
时间窗: From 0 to 24 hours after dosing on Days 122 and 132.
Measured in nanomoles per liter(nmol/L).
Adjusted tmax,sema; time to adjusted maximum observed semaglutide plasma concentration
时间窗: From 0 to 24 hours after dosing on Days 122 and 132.
Measured in hours.
t½,sema; the terminal half-life of semaglutide
时间窗: From 0 to 840 hours after dosing on Day 132.
Measured in hours.
次要结局
未报告次要终点