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A Study in Healthy Men to Test How Fluconazole Influences the Amount of BI 425809 in the Blood
Sponsor: Boehringer Ingelheim
Summary
The main objective of this trial is to investigate the effect of fluconazole, under steady state conditions on the pharmacokinetics of BI 425809 (Reference Treatment R: BI 425809 alone; Test Treatment T: BI 425809 given under steady state conditions of fluconazole).
Official title: Effect of Fluconazole on the Pharmacokinetics of a Single Oral Dose of BI 425809 in Healthy Male Subjects (an Open-label, Two-period Fixed-sequence Design Study)
Key Details
Gender
MALE
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2021-10-19
Completion Date
2022-01-10
Last Updated
2026-05-04
Healthy Volunteers
Yes
Conditions
Interventions
BI 425809
Single oral dose of BI 425809 as film-coated tablet on Day 1 of period 1. Single oral dose of BI 425809 as film-coated tablet on Day 1 of period 2.
fluconazole
Fluconazole orally as hard capsules once daily for 13 days (Day -4 up to Day 9) in period 2.
Locations (1)
Humanpharmakologisches Zentrum Biberach
Biberach, Germany