NCT06360081

A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers

Bioequivalence of Zongertinib Tablets From Two Different Manufacturers Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Trial)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to establish the bioequivalence of zongertinib tablet from manufacturer 1 (Test, T) compared with zongertinib tablet from manufacturer 2 (reference, R) following oral administration.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Zongertinib manufacturer 1	Zongertinib
DRUG	Zongertinib manufacturer 2	Zongertinib

Timeline

• Start date: 2024-04-30
• Primary completion: 2024-06-30
• Completion: 2024-07-15
• First posted: 2024-04-11
• Last updated: 2025-09-22
• Results posted: 2025-09-22

Locations

1 site across 1 country: Germany