The main objective of this trial is to investigate the relative bioavailability of a single dose of BI 1358894 administered as tablet formulation 2 (TF2a, TF2b) under fasted conditions compared with the tablet formulation 1 (TF1) of BI 1358894 under fed conditions following oral administration and to investigate the effect of food on the exposure with TF2 (TF2a, TF2b).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Tablet formulation 2 (TF2a), fed
Tablet formulation 2 (TF2a), fasted
Tablet formulation 2 (TF2b), fed
CRS Clinical Research Services Mannheim GmbH
Mannheim, Germany
Maximum Measured Concentration of BI 1358894 in Plasma (Cmax)
Maximum measured concentration of BI 1358894 in plasma (Cmax).
Time frame: Within 2 hours (h) before and at 10 minutes (min), 20min, 30min, 1h, 1h30min, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 240h, 312h after drug administration in each treatment period.
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Time frame: Within 2 hours (h) before and at 10 minutes (min), 20min, 30min, 1h, 1h30min, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 240h, 312h after drug administration in each treatment period.
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Time frame: Within 2 hours (h) before and at 10 minutes (min), 20min, 30min, 1h, 1h30min, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 240h, 312h after drug administration in each treatment period.
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)
Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to 72 hours (AUC0-72).
Time frame: Within 2 hours (h) before and at 10 minutes (min), 20min, 30min, 1h, 1h30min, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration in each treatment period.
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Tablet formulation 2 (TF2b), fasted
Tablet formulation 1 (TF1), fed