A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of Semaglutide to Healthy Male Participants - Oral Formulation III
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve
研究概览
简要总结
In this study, a known medicine called 'semaglutide' will be tested in two different tablet versions. The two tablets differ in the way these have been manufactured. The aim of the study is to investigate the amount of active ingredient in the blood after dosing the different tablet versions. Participants will receive one tablet version for 10 days (first treatment period) and the other version for 10 days (second treatment period). The treatment arm participants will be assigned to is decided by chance. The study will last for about 23 weeks for each participant. 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sequence 1: Semaglutide J then Semaglutide K
Oral semaglutide J will be administered in treatment period 1 followed by semaglutide K in treatment period 2.
干预措施: Semaglutide (Drug)
Sequence 2: Semagultide K then Semaglutide J
Oral semaglutide K will be administered in treatment period 1 followed by semaglutide J in treatment period 2.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve
时间窗: From 0 to 24 hours after dosing on day 80 and 90
Measured in hour\*nanomoles per liter (h\*nmol/L).
次要结局
- t½,sema; the terminal half-life of semaglutide(From 0 to 840 hours after dosing on day 90)
- Adjusted Cmax,0-24h,sema; adjusted maximum observed semaglutide plasma concentration(From 0 to 24 hours after dosing on day 80 and 90)
- Adjusted tmax,0-24h,sema; time to adjusted maximum observed semaglutide plasma concentration(From 0 to 24 hours after dosing on day 80 and 90)