Relative Bioavailability of Two BI 456906 Formulations After Subcutaneous Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
研究概览
简要总结
The main objective of this trial is to investigate relative bioavailability of BI 456906 reference formulation (Formulation A) vs. BI 456906 test formulation (Formulation B2).
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
- •Trial participants will only be included in the trial if they meet the following criteria:
- •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)
- •Body Mass Index (BMI) of 18.5 to 29.9 kg/m (inclusive)
- •Signed and dated written informed consent in accordance with ICH-GCP (Harmonized Guideline for Good Clinical Practice) and local legislation prior to admission to the trial Further inclusion criteria apply.
排除标准
- •Participants will not be allowed to participate, if any of the following general criteria apply:
- •Any finding in the medical examination (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 and, in particular:
- •Alanine aminotransferase (ALT) above upper limit of normal (ULN) + 20%
- •Aspartate aminotransferase (AST) above Upper limit of normal (ULN) + 20%
- •Gamma Glutamil Transferase (GGT) above Upper limit of normal (ULN) + 20%
- •Lipase or amylase above Upper limit of normal (ULN) + 20%
- •Bilirubin above 1.2x Upper limit of normal (ULN) (except for cases of Gilbert's Syndrome)
- •Estimated Glomerular Filtration Rate Estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1.73 m²
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
研究组 & 干预措施
BI 456906 formulation A then BI 456906 formulation B2
BI 456906 formulation A = Reference treatment BI 456906 formulation B2 = Test treatment
干预措施: BI 456906 formulation A (Combination Product)
BI 456906 formulation A then BI 456906 formulation B2
BI 456906 formulation A = Reference treatment BI 456906 formulation B2 = Test treatment
干预措施: BI 456906 formulation B2 (Drug)
BI 456906 formulation B2 then BI 456906 formulation A
BI 456906 formulation A = Reference treatment BI 456906 formulation B2 = Test treatment
干预措施: BI 456906 formulation A (Combination Product)
BI 456906 formulation B2 then BI 456906 formulation A
BI 456906 formulation A = Reference treatment BI 456906 formulation B2 = Test treatment
干预措施: BI 456906 formulation B2 (Drug)
结局指标
主要结局
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
时间窗: Up to 22 days.
Cmax (maximum measured concentration of the analyte in plasma)
时间窗: Up to 22 days.
次要结局
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(Up to 22 days.)