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)
Sponsor study identifier
Secondary identifiers
REGISTRY · WHO International Clinical Trials Registry Platform (ICTRP)
REGISTRY · CTIS
interventional
56
1 country
1
Study Start
September 9, 2026
Actual (reported)Primary Completion
December 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 21, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The main objective of this trial is to establish the bioequivalence of Zongertinib tablets from two different manufacturers following oral administration.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 21, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 24, 2026
Actual (reported)August 27, 2026
Actual (reported)September 9, 2026
Actual (reported)December 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 21, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Time from dosing to maximum measured concentration of the analyte in plasma (tmax)
up to 4 days
Test product, fasted condition Reference product, fasted condition Test product, fed condition Reference product, fed condition
Reference product, fasted condition Reference product, fed condition Test product, fasted condition Test product, fed condition
Zongertinib, Formulation A, reference product
Humanpharmakologisches Zentrum Biberach
Biberach, 88397, Germany
First Submitted
August 24, 2026
First Posted
August 27, 2026
Study Start
September 9, 2026
Actual (reported)Primary Completion
December 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Test product, fed condition Test product, fasted condition Reference product, fed condition Reference product, fasted condition
Reference product, fed condition Test product, fed condition Reference product, fasted condition Test product, fasted condition
Zongertinib Formulation B, test product
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Completion
December 21, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 15, 2026
Record last verified: 2026-09
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
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