The main objective of this trial is to investigate the relative bioavailability of vicadrostat and empagliflozin when administered in combination or individually.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Vicadrostat
Jardiance®
Humanpharmakologisches Zentrum Biberach
Biberach, Germany
Area under the concentration-time curve of vicadrostat in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Reference 1 (Days 1, 2 and 3), Test (Days 1, 2 and 3)
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Reference 2 (Days 1, 2, 3 and 4), Test (Days 1, 2, 3 and 4)
Maximum measured concentration of vicadrostat in plasma (Cmax)
Time frame: Reference 1 (Days 1, 2 and 3), Test (Days 1, 2 and 3)
Maximum measured concentration of empagliflozin in plasma (Cmax)
Time frame: Reference 2 (Days 1, 2, 3 and 4), Test (Days 1, 2, 3 and 4)
Area under the concentration-time curve of vicadrostat in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz )
Time frame: Reference 1 (Days 1, 2 and 3), Test (Days 1, 2 and 3)
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: Reference 2 (Days 1, 2, 3 and 4), Test (Days 1, 2, 3 and 4)
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