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

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.

Timeline

Start

2024-04-30

Primary completion

2024-06-30

Completion

2024-07-15

Outcome

Met primary endpoint

registry Ratio of adjusted geometric means (T/R) 99.89 (90% CI 97.08 to 102.78) NCT06360081 ↗

registry Ratio of adjusted geometric means (T/R) 100.83 (90% CI 96.43 to 105.44) NCT06360081 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zongertinib	Small molecule	60 mg	Oral

Indications

No indication recorded.