The main objective of this trial is to establish the bioequivalence of two different formulations of vicadrostat / empagliflozin in healthy male and female trial participants following oral administration.
Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure, Pulse rate), 12-lead Electrocardiogram, and clinical laboratory tests
Age of 18 to 55 years (inclusive)
Body mass index of 18.5 to 29.9 kg / m² (inclusive)
Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice and local legislation prior to admission to the trial
Any finding in the medical examination (including Blood pressure, Pulse rate or Electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Crossover
Vicadrostat
DrugVicadrostat
Empagliflozin
DrugEmpagliflozin
Vicadrostat + empagliflozin
DrugVicadrostat + empagliflozin combined
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Maximum measured concentration of the analyte in plasma (Cmax)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
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