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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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 orally as hard capsules once daily for 13 days (Day -4 up to Day 9) in period 2.
Humanpharmakologisches Zentrum Biberach
Biberach, Germany
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 215 h Post Administration of BI 425809 (AUC0-215)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 215 h post administration of BI 425809 (AUC0-215) is reported.
Time frame: Within 3 hours (h) before and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 47h, 71h, 119h, 167h and 215h after administration of BI 425809 on Day 1 of each period.
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
Maximum measured concentration of BI 425809 in plasma (Cmax) is reported.
Time frame: Within 3 hours (h) before and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 47h, 71h, 119h, 167h and 215h after administration of BI 425809 on Day 1 of each period.
Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.
Time frame: Within 3 hours (h) before and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 47h, 71h, 119h, 167h and 215h after administration of BI 425809 on Day 1 of each period.
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