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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Zongertinib, Formulation A, reference product; Drug: Zongertinib Formulation B, test product

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Boehringer Ingelheim; Phone Number: 1-800-243-0127; Email: clintriage.rdg@boehringer-ingelheim.com

Study Locations

• Germany
  • Biberach, Germany, 88397
    • Recruiting
    • Humanpharmakologisches Zentrum Biberach
    • Contact: Boehringer Ingelheim; Phone Number: 08007234742; Email: deutschland@bitrialsupport.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment sequence 1; Test product, fasted condition Reference product, fasted condition Test product, fed condition Reference product, fed condition	Drug: Zongertinib, Formulation A, reference product; Zongertinib, Formulation A, reference product; Other Names: BI 1810631; Drug: Zongertinib Formulation B, test product; Zongertinib Formulation B, test product; Other Names: BI 1810631
Experimental: Treatment sequence 2; Reference product, fasted condition Reference product, fed condition Test product, fasted condition Test product, fed condition	Drug: Zongertinib, Formulation A, reference product; Zongertinib, Formulation A, reference product; Other Names: BI 1810631; Drug: Zongertinib Formulation B, test product; Zongertinib Formulation B, test product; Other Names: BI 1810631
Experimental: Treatment sequence 3; Test product, fed condition Test product, fasted condition Reference product, fed condition Reference product, fasted condition	Drug: Zongertinib, Formulation A, reference product; Zongertinib, Formulation A, reference product; Other Names: BI 1810631; Drug: Zongertinib Formulation B, test product; Zongertinib Formulation B, test product; Other Names: BI 1810631
Experimental: Treatment sequence 4; Reference product, fed condition Test product, fed condition Reference product, fasted condition Test product, fasted condition	Drug: Zongertinib, Formulation A, reference product; Zongertinib, Formulation A, reference product; Other Names: BI 1810631; Drug: Zongertinib Formulation B, test product; Zongertinib Formulation B, test product; Other Names: BI 1810631

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 21, 2026

Study Registration Dates

• First Submitted: August 24, 2026
• First Submitted That Met QC Criteria: August 24, 2026
• First Posted (Actual): August 27, 2026

Study Record Updates

• Last Update Posted (Actual): September 15, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1479-0067; U1111-1335-5272 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP)); 2026-525696-77 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No