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)

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07789028

Enrollment

Registered

2026-08-27

Start date

2026-09-09

Completion date

2026-12-21

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGZongertinib, Formulation A, reference product

Zongertinib, Formulation A, reference product

DRUGZongertinib Formulation B, test product

Zongertinib Formulation B, test product

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Area under the concentration-time curve of the analyte in plasma over the time interval from 0-72h (AUC0-72h)	up to 4 days
Maximum measured concentration of the analyte in plasma (Cmax)	up to 4 days

Secondary

Measure	Time frame
Time from dosing to maximum measured concentration of the analyte in plasma (tmax)	up to 4 days

Countries

Germany

Contacts

CONTACTBoehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com1-800-243-0127

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026