A Study in Healthy People to Test How Zongertinib is Taken up in the Body When Given as Tablets Made by Two Different Manufacturers With or Without Food

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)

The main objective of this trial is to establish the bioequivalence of Zongertinib tablets from two different manufacturers following oral administration.

Inclusion criteria :

1. 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
2. Age of 18 to 50 years (inclusive)
3. Body mass index of 18.5 to 29.9 kg/m² (inclusive)
4. 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
5. Further inclusion criteria apply.

Exclusion criteria :

1. Any finding in the medical examination (including BP, PR rate or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. 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
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Further exclusion criteria apply.