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A Study in Healthy People to Compare 2 Different Formulations of BI 1358894 Tablets Taken With or Without Food

NCT05155306 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-02-26

Study results available
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Summary

To investigate the relative bioavailability of the intended Commercial Formulation (iCF) (Test, T) compared with Trial Formulation 2 (TFII) (Reference, R) and to assess potential food effects following oral administration of BI 1358894.

Conditions

  • Healthy

Interventions

DRUG

BI 1358894, intended Commercial Formulation (iCF) (T)

A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning

DRUG

BI 1358894, Trial Formulation 2 (TFII) (R)

A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-14
Primary Completion
2022-05-16
Completion
2022-05-16
FDA Drug
Yes

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05155306 on ClinicalTrials.gov