Bioequivalence of Survodutide (BI 456906) When Administered Via Pre-filled Syringe (Formulation A) and Pre Filled Pen (Formulation B2) in Male and Female Trial Participants Who Are Healthy or Otherwise Healthy With Overweight/Obesity (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Trial)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
研究概览
简要总结
The goal of this study is to find out whether different formulations of survodutide given by different delivery methods is taken up in the body in a similar way.
Participants visit the study site regularly. During study visits, the doctors collect information about participants' health. To assess the study endpoints, participants regularly have blood samples taken.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female trial participant who is healthy or otherwise healthy with overweight/obesity according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- •Age of 18 to 55 years (inclusive)
- •Body mass index (BMI) of 22.0 to 39.9 kg/m2 (inclusive)
- •Signed and dated written informed consent in accordance with international council for harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply.
排除标准
- •Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- •Repeated measurement of systolic BP outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 45 to 90 beats per minute (bpm)
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
研究组 & 干预措施
Survodutide formulation A then Survodutide formulation B2
Survodutide formulation A = Reference treatment Survodutide formulation B2 = Test treatment
干预措施: Survodutide formulation B2 (Combination Product)
Survodutide formulation B2 then Survodutide formulation A
Survodutide formulation A = Reference treatment Survodutide formulation B2 = Test treatment
干预措施: Survodutide formulation A (Combination Product)
Survodutide formulation B2 then Survodutide formulation A
Survodutide formulation A = Reference treatment Survodutide formulation B2 = Test treatment
干预措施: Survodutide formulation B2 (Combination Product)
Survodutide formulation A then Survodutide formulation B2
Survodutide formulation A = Reference treatment Survodutide formulation B2 = Test treatment
干预措施: Survodutide formulation A (Combination Product)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
时间窗: Up to Day 22
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: Up to Day 22
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
时间窗: Up to Day 22
次要结局
未报告次要终点