MedTrace Logo

A Study in Healthy People to Test if Taking Different Formulations of BI 425809 Tablets Influences the Amount of BI 425809 in the Blood

NCT03817476 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-24

Study results available
· View outcomes & findings →

Summary

The main objective of this trial is to investigate the relative bioavailability of batch 1 of the intended commercial tablet formulation (iCF1) of BI 425809 vs batch 2 of the intended commercial tablet formulation (iCF2) of BI 425809 vs BI 425809 (TF2) formulation.

Conditions

  • Healthy

Interventions

DRUG

iCF1(T1) 25 milligram BI 425809

One 25 milligram BI 425809 iCF1 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours.

DRUG

iCF2(T2) 25 milligram BI 425809

One 25 milligram BI 425809 iCF2 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours.

DRUG

TF2(R) 25 milligram BI 425809

One 25 milligram BI 425809 TF2 tablet. Oral with 240 milliliter of water after an overnight fast of at least 10 hours.

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
2019-02-11
Primary Completion
2019-05-28
Completion
2019-05-28

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 NCT03817476 on ClinicalTrials.gov