A Trial to Demonstrate Bioequivalence Between Semaglutide Formulations for the DV3372 Device 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
- 68
- 试验地点
- 1
- 主要终点
- AUC0-last,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until last quantifiable measurement after a single dose subcutaneous semaglutide administration
研究概览
简要总结
This study will compare four different semaglutide versions and different injection tools. The study aims to show similar levels of semaglutide in the blood using different versions of semaglutide. The researchers also want to look at how well the injection tools work. Participants will get two versions of semaglutide at two separate dosing visits. One of them is a version that doctors already can prescribe and the other will be one of the new versions. Which version participants get first is decided by chance. Participants will get semaglutide as an injection under the skin. The time between injections is 7 to 8 weeks. The study will last for about 16 weeks. Participants will have 27 study visits with the study doctor. For two of the visits, participants will stay at the clinic for 4 days and 3 nights.
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 29.9 kg/m^2 (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
- •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, within 14 days prior to the day of screening.
- •Abuse or intake of alcohol, defined as any of the below: a) Known or suspected alcohol abuse within 1 year prior to the day of screening (defined as regular intake of more than 24 g alcohol daily for men and 12 g alcohol daily for women. b) Positive alcohol test at screening.
- •Abuse or intake of drugs, defined as any of the below: a) Known or suspected drug/chemical substance abuse within 1 year prior to the day of screening. b) Positive drug of abuse test at screening.
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly affective contraceptive methods.
研究组 & 干预措施
Cohort 3: Semaglutide 0.5 mg
Participants will receive a single dose of semaglutide 2.0 mg/mL using NovoPen®4 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.
干预措施: Semaglutide, 1.34 mg/mL (Drug)
Cohort 1: Semaglutide 0.25 mg
Participants will receive a single dose of semaglutide 0.5 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.
干预措施: Semaglutide, 0.5 mg/mL (Drug)
Cohort 1: Semaglutide 0.25 mg
Participants will receive a single dose of semaglutide 0.5 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.
干预措施: Semaglutide, 1.34 mg/mL (Drug)
Cohort 1: Semaglutide 0.25 mg
Participants will receive a single dose of semaglutide 0.5 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.
干预措施: DV3372, 0.5 mg/mL (Device)
Cohort 1: Semaglutide 0.25 mg
Participants will receive a single dose of semaglutide 0.5 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.
干预措施: PDS290 (Device)
Cohort 2: Semaglutide 0.5 mg
Participants will receive a single dose of semaglutide 1.0 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.
干预措施: Semaglutide, 1.0 mg/mL (Drug)
Cohort 2: Semaglutide 0.5 mg
Participants will receive a single dose of semaglutide 1.0 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.
干预措施: Semaglutide, 1.34 mg/mL (Drug)
Cohort 2: Semaglutide 0.5 mg
Participants will receive a single dose of semaglutide 1.0 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.
干预措施: DV3372, 1.0 mg/mL (Device)
Cohort 2: Semaglutide 0.5 mg
Participants will receive a single dose of semaglutide 1.0 mg/mL using DV3372 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.
干预措施: PDS290 (Device)
Cohort 3: Semaglutide 0.5 mg
Participants will receive a single dose of semaglutide 2.0 mg/mL using NovoPen®4 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.
干预措施: Semaglutide, 2.0 mg/mL (Drug)
Cohort 3: Semaglutide 0.5 mg
Participants will receive a single dose of semaglutide 2.0 mg/mL using NovoPen®4 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.
干预措施: PDS290 (Device)
Cohort 3: Semaglutide 0.5 mg
Participants will receive a single dose of semaglutide 2.0 mg/mL using NovoPen®4 device and a single dose of semaglutide 1.34 mg/mL using PDS290 device in a cross-over manner at two separate dosing visits. The dosing visits will be separated by a wash-out period of 2-3 weeks.
干预措施: NovoPen®4 (Device)
结局指标
主要结局
AUC0-last,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until last quantifiable measurement after a single dose subcutaneous semaglutide administration
时间窗: 0-840 hours (5 weeks)
Measured in nmol·h/L.
Cmax,sema,SD, the maximum plasma semaglutide concentration after a single dose subcutaneous semaglutide administration
时间窗: 0-840 hours (5 weeks)
Measured in nmol/L.
次要结局
- t½,sema,SD, terminal elimination half-life of semaglutide(0-840 hours (5 weeks))
- AUC0-∞,sema,SD, the area under the plasma semaglutide concentration curve from time 0 until infinity after a single dose subcutaneous semaglutide administration(0-840 hours (5 weeks))
- tmax,sema,SD, time to Cmax,sema,SD of semaglutide(0-840 hours (5 weeks))
- Cl/F,sema,SD, total apparent clearance of semaglutide(0-840 hours (5 weeks))
- Vz/F,sema,SD, apparent volume of distribution of semaglutide(0-840 hours (5 weeks))
- Number of site-initiated technical complaints with or without co-reported adverse events: DV3372 device, 1.0 mg/mL versus PDS290 semaglutide pen-injector, 1.34 mg/mL(Week 0-5 in both treatment period 1 and 2)
- Number of site-initiated technical complaints with or without co-reported adverse events: DV3372 device, 0.5 mg/mL versus PDS290 semaglutide pen-injector, 1.34 mg/mL(Week 0-5 in both treatment period 1 and 2)