Relative Bioavailability of Two Different BI 3034701 Treatments Following Subcutaneous Administration in Healthy Male and Female Participants (an Open-label, Randomised, Single-dose, Two-period, Two-sequence, Crossover Trial)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 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 aim of the trial is to investigate relative bioavailability of BI 3034701 treatment T vs. BI 3034701 treatment R.
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
- •Healthy male or female trial participant 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) at screening
- •Body mass index (BMI) of 20.0 to 32.0 kg/m^2 (inclusive) at screening
- •Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) and local legislation prior to admission to the trial
- •Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
排除标准
- •Any finding in the medical examination (including BP, PR or ECG) deviating from and assessed as clinically relevant by the investigator
- •Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- •Further exclusion criteria apply.
研究组 & 干预措施
Test treatment (T), then Reference treatment (R)
BI3034701 formulation C1 (T), then BI3034701 formulation B (R)
干预措施: BI3034701 formulation B (Drug)
Test treatment (T), then Reference treatment (R)
BI3034701 formulation C1 (T), then BI3034701 formulation B (R)
干预措施: BI3034701 formulation C1 (Drug)
Reference treatment (R), then Test treatment (T)
BI3034701 formulation B (R), then BI3034701 formulation C1 (T)
干预措施: BI3034701 formulation B (Drug)
Reference treatment (R), then Test treatment (T)
BI3034701 formulation B (R), then BI3034701 formulation C1 (T)
干预措施: BI3034701 formulation C1 (Drug)
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 19 days.
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: Up to 19 days.
Highest observed plasma concentrations within the time interval.
次要结局
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(Up to 19 days.)