NCT06408870

A Study in Healthy People to Compare How 2 Different Low Dose Formulations of BI 1015550 Are Taken up in the Body

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (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 the BI 1015550 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R) following a single oral dose administration.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1015550	Participants received two formulations of nerandomilast separated by a washout period

Timeline

• Start date: 2024-06-06
• Primary completion: 2024-08-28
• Completion: 2024-08-28
• First posted: 2024-05-10
• Last updated: 2025-12-01
• Results posted: 2025-12-01

Locations

1 site across 1 country: Germany