A Trial to Demonstrate Bioequivalence Between the Semaglutide D Formulation for the DV3396 Pen-Injector and the Formulation for the PDS290 Pen-Injector Following Subcutaneous Administration of 2 mg Semaglutide
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- AUC0-last,sema,2mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period
研究概览
简要总结
The study will look at how 2 different semaglutide versions reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different semaglutide versions. Participants will get 1 of the 2 versions of semaglutide - which version is decided by chance. One version is the one that doctors already can prescribe and the other is the new version. Participants will get the medicine as an injection under the skin of the belly with a pen-injector. The type of pen-injector is different for the 2 versions of semaglutide. Participants will receive 7 once-weekly injections in total. The study will last for about 80-106 days. Participants will have 19 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic, 1 visit for 2 days and 1 night and the other visit 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. Participants cannot take part in this study if they have any disease or disorder that the study doctor thinks is a health problem. 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
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent.
- •Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- •Body weight between 65.0 and 130.0 kg (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
- •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.
- •Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, highly effective contraceptives and occasional use of paracetamol and acetylsalicylic acid (the two latter are not allowed within 24 hours before screening), within 14 days prior to the day of screening.
- •Abuse or intake of alcohol, defined as any of the below:
- •Known or suspected alcohol abuse within 1 year prior to the day of screening (defined as regular intake of more than an average intake of 24 g alcohol daily for men and 12 g alcohol daily for women -12 g of alcohol equals about 300 mL of beer or lager, 100 mL of wine, or 25 mL spirits)
- •Positive alcohol test at screening
- •Abuse or intake of drugs, defined as any of the below:
- •Known or suspected drug/chemical substance abuse within 1 year prior to the day of screening
- •Positive drug of abuse test at screening
研究组 & 干预措施
DV3396
Participants will receive once-weekly doses of semaglutide administered with the DV3396 pen-injector (test drug product)
干预措施: Semaglutide (administered by DV3396 pen-injector) (Drug)
PDS290
Participants will receive once-weekly doses of semaglutide administered with the PDS290 pen-injector (comparator drug product)
干预措施: Semaglutide (administered by PDS290 pen-injector) (Drug)
结局指标
主要结局
AUC0-last,sema,2mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period
时间窗: 0-840 hours after one dose of s.c. semaglutide 2 mg
h\*nmol/L
Cmax,sema,2mg: Maximum observed semaglutide concentration after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period
时间窗: 0-840 hours after one dose of s.c. semaglutide 2 mg
nmol/L
次要结局
- t½,sema,2mg: terminal elimination half-life of semaglutide after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period(0-840 hours after one dose of s.c. semaglutide 2 mg)
- AUC0-∞,sema,2mg: Area under the semaglutide concentration time curve from time 0 until infinity after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period(0-840 hours after one dose of s.c. semaglutide 2 mg)
- tmax,sema,2mg: Time of maximum observed semaglutide concentration after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period(0-840 hours after one dose of s.c. semaglutide 2 mg)