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NOT YET RECRUITING
NCT07789028
PHASE1

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

View on ClinicalTrials.gov

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

DRUG

Zongertinib, Formulation A, reference product

Zongertinib, Formulation A, reference product

DRUG

Zongertinib Formulation B, test product

Zongertinib Formulation B, test product

Locations (1)

Humanpharmakologisches Zentrum Biberach

Biberach, Germany