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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
Sponsor: Boehringer Ingelheim
Summary
The main objective of this trial is to establish the bioequivalence of Zongertinib tablets from two different manufacturers following oral administration.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2026-09-09
Completion Date
2026-12-21
Last Updated
2026-08-27
Healthy Volunteers
Yes
Conditions
Interventions
Zongertinib, Formulation A, reference product
Zongertinib, Formulation A, reference product
Zongertinib Formulation B, test product
Zongertinib Formulation B, test product
Locations (1)
Humanpharmakologisches Zentrum Biberach
Biberach, Germany