The main objective of this trial is to establish the bioequivalence of Zongertinib tablets from two different manufacturers following oral administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Zongertinib, Formulation A, reference product
Zongertinib Formulation B, test product
Humanpharmakologisches Zentrum Biberach
Biberach, Germany
RECRUITINGArea under the concentration-time curve of the analyte in plasma over the time interval from 0-72h (AUC0-72h)
Time frame: up to 4 days
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 4 days
Time from dosing to maximum measured concentration of the analyte in plasma (tmax)
Time frame: up to 4 days
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