Zongertinib tablets from two makers: do they behave the same when taken with or without food

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial in healthy adults compares two Zongertinib tablet formulations to determine bioequivalence after oral dosing. Participants are healthy men and women aged 18–50 who meet safety criteria, and the study involves standard clinical assessments, blood tests, ECGs, and monitoring to measure drug exposure. Participants receive Zongertinib Formulation A (reference) and Formulation B (test) under controlled conditions and with attention to potential food effects. The trial aims to establish that the two formulations yield similar pharmacokinetics, which could support interchangeable use if both are safe and effective.

Why it matters

Who can join: the full rules

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.

Where it's running

• Humanpharmakologisches Zentrum Biberach
  Biberach, Germany Recruiting

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.