Bioequivalence of Zongertinib Tablets From Two Different Manufacturers Following Oral Administration in Healthy Male and Female Trial Participants in Fasted and Fed State (an Open-label, Randomised, Single-dose, Four-period, Four-sequence Crossover Trial)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0-72h (AUC0-72h)
研究概览
简要总结
The main objective of this trial is to establish the bioequivalence of Zongertinib tablets from two different manufacturers following oral administration.
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 50 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 50 years (inclusive)
- •Body mass index of 18.5 to 29.9 kg/m² (inclusive)
- •Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice 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 rate or ECG) deviating from normal 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 45 to 90 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
Treatment sequence 4
Reference product, fed condition Test product, fed condition Reference product, fasted condition Test product, fasted condition
干预措施: Zongertinib, Formulation A, reference product (Drug)
Treatment sequence 3
Test product, fed condition Test product, fasted condition Reference product, fed condition Reference product, fasted condition
干预措施: Zongertinib, Formulation A, reference product (Drug)
Treatment sequence 4
Reference product, fed condition Test product, fed condition Reference product, fasted condition Test product, fasted condition
干预措施: Zongertinib Formulation B, test product (Drug)
Treatment sequence 1
Test product, fasted condition Reference product, fasted condition Test product, fed condition Reference product, fed condition
干预措施: Zongertinib, Formulation A, reference product (Drug)
Treatment sequence 1
Test product, fasted condition Reference product, fasted condition Test product, fed condition Reference product, fed condition
干预措施: Zongertinib Formulation B, test product (Drug)
Treatment sequence 2
Reference product, fasted condition Reference product, fed condition Test product, fasted condition Test product, fed condition
干预措施: Zongertinib, Formulation A, reference product (Drug)
Treatment sequence 2
Reference product, fasted condition Reference product, fed condition Test product, fasted condition Test product, fed condition
干预措施: Zongertinib Formulation B, test product (Drug)
Treatment sequence 3
Test product, fed condition Test product, fasted condition Reference product, fed condition Reference product, fasted condition
干预措施: Zongertinib Formulation B, test product (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 0-72h (AUC0-72h)
时间窗: up to 4 days
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: up to 4 days
次要结局
- Time from dosing to maximum measured concentration of the analyte in plasma (tmax)(up to 4 days)