At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 64 enrolled
Drug / intervention
BI 1015550drug
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 the BI 1015550 Low Dose Formulation C2 and the BI 1015550 Low Dose Formulation C1 (Phase 3 Formulation) Following Oral Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)
In Brief
A Phase 1 clinical trial evaluating BI 1015550 for Healthy. Completed, enrolled 64 participants across 1 site.
Detailed Summary
The main objective of this trial is to establish the bioequivalence of the BI 1015550 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R) following a single oral dose administration.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20252026
First PostedMay 2024
Enrollment StartJun 2024
Primary CompletionAug 2024
TodayJul 2026
First PostedMay 10, 2024
Enrollment StartJun 6, 2024
Primary CompletionAug 28, 2024
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 2.1 years ago
Interventions
BI 1015550drug
Participants received two formulations of nerandomilast separated by a washout period