A Trial to Demonstrate Bioequivalence Between Semaglutide Drug Product Concentrations 0.68 mg/mL and 1.0 mg/mL
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Area under the semaglutide plasma concentration curve from 0 to tz
研究概览
简要总结
The study will look at how two different versions of semaglutide reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different versions. Participants will get both versions of semaglutide. The order in which participants receive the versions is decided by chance. Participants will get the medicines as an injection under the skin of the belly with the use of a pen-injector. The study will last for about 11 to 17 weeks. Participants will have 27 visits with the study doctor. At 2 visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
- •Body mass index between 20.0 and 27.0 kg/m^2 (both inclusive).
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
- •Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
研究组 & 干预措施
Semaglutide 0.68 mg/mL
Semaglutide administered with the PDS290 pen-injector
干预措施: Semaglutide (Drug)
Semaglutide 1.0 mg/mL
Semaglutide administered with the PDS290 pen-injector
干预措施: Semaglutide (Drug)
结局指标
主要结局
Area under the semaglutide plasma concentration curve from 0 to tz
时间窗: 0-840 hours
h\*nmol/L
Maximum semaglutide plasma concentration
时间窗: 0-840 hours
nmol/L
次要结局
- Time to Cmax for semaglutide(0-840 hours)
- Terminal elimination half-life(0-840 hours)
- Total apparent clearance of semaglutide(0-840 hours)
- Area under the semaglutide plasma concentration curve(0-840 hours)
- Apparent volume of distribution of semaglutide(0-840 hours)