At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 56 enrolled
Drug / intervention
Zongertinib manufacturer 1 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating Zongertinib manufacturer 1 and Zongertinib manufacturer 2 for Healthy. Completed, enrolled 56 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20252026
First PostedApr 2024
Enrollment StartApr 2024
Primary CompletionJun 2024
Study CompletionJul 2024
TodayJul 2026
First PostedApr 11, 2024
Enrollment StartApr 30, 2024
Primary CompletionJun 30, 2024
Study CompletionJul 15, 2024
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 2.2 years ago
Interventions
Zongertinib manufacturer 1drug
Zongertinib
Zongertinib manufacturer 2drug
Zongertinib