A Study to Demonstrate Bioequivalence Between Semaglutide Formulation for the DV3396 Pen-injector and the Formulation for the PDS290 Semaglutide Pen-injector
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- AUC0-last,sema 0.5mg: Area under the semaglutide concentration-time curve from time 0 until last quantifiable measurement after single dose of s.c. semaglutide 0.5 mg
研究概览
简要总结
In this trial, two approved solutions of the medicine semaglutide will be compared in healthy volunteers. The purpose of this trial is to see if semaglutide B and semaglutide D solutions are comparable with regards to moving into, through and out of the body when given in two separate injections. Participants will receive semaglutide B and semaglutide D in different periods of the trial (Period 1 and Period 2). Participants will receive 1 subcutaneous injection of semaglutide B (0.5 mg) and 1 subcutaneous injection of semaglutide D (0.5 mg). The trial will last for 87 to 120 days (about 3 to 4 months), depending on how long the screening period (2 to 28 days) and washout period (14 to 21 days) are. Participants will have a screening visit, followed by an in house stay (5 nights/6 days) and 9 visits for each period. Participants will have to fast for at least 6 hours overnight with only water allowed before receiving the trial medicine on the second day of in house stay (Day 1) in Period 1 and Period 2.
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
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Aged 20-55 years (both inclusive) at the time of signing informed consent
- •Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m^2) (both inclusive)
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method
- •Any disorder 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 medications, highly effective contraceptives and occasional use of paracetamol and acetylsalicylic acid, 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 before screening (defined as regular intake of more than an average intake of 24 grams (g) alcohol daily for men and 12 g alcohol daily for women - 12 g of alcohol equals about 300 milliliters (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 or chemical substance abuse within 1 year before screening
- •Positive drug of abuse test at screening
研究组 & 干预措施
Semaglutide B, 1.34 mg/mL followed by Semaglutide D, 1.0 mg/mL
干预措施: Semaglutide B, 1.34 mg/mL (Drug)
Semaglutide B, 1.34 mg/mL followed by Semaglutide D, 1.0 mg/mL
干预措施: Semaglutide D, 1.0 mg/mL (Drug)
Semaglutide D, 1.0 mg/mL followed by Semaglutide B, 1.34 mg/mL
干预措施: Semaglutide D, 1.0 mg/mL (Drug)
Semaglutide D, 1.0 mg/mL followed by Semaglutide B, 1.34 mg/mL
干预措施: Semaglutide B, 1.34 mg/mL (Drug)
结局指标
主要结局
AUC0-last,sema 0.5mg: Area under the semaglutide concentration-time curve from time 0 until last quantifiable measurement after single dose of s.c. semaglutide 0.5 mg
时间窗: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Measured in h\*nmol/L
Cmax,sema,0.5mg: maximum observed semaglutide concentration-time after single dose of s.c. semaglutide 0.5 mg administration
时间窗: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Measured in nmol/L
次要结局
未报告次要终点