| Outcome Measures: |
Primary: Global assessment of tolerability by the investigator on a 4-point scale (good, satisfactory, not satisfactory and bad), Day 43|Number of patients with adverse events, Up to day 50|Number of patients with clinically relevant changes in vital signs (blood pressure, pulse rate), Up to day 50|Number of patients with clinically relevant changes in clinical laboratory tests (haematology, clinical chemistry, and urinalysis), Up to day 50 | Secondary: Maximum measured concentration of the analyte in plasma (Cmax) at different time points, Up to day 43|Time from last dosing to the maximum concentration of the analyte in plasma (tmax) at different time points, Up to day 43|Area under the concentration time curve of the analyte in plasma (AUC) at different time points, Up to day 43|Amount of the analyte that is eliminated in urine (Ae) at different time points, Up to day 43|Fraction of parent drug eliminated in urine (fe) at different time points, Up to day 43|Renal clearance of the analyte (CLR) at different time points, Up to day 43|Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss), After the last dose on day 28 up to day 43|Average concentration of the analyte in plasma at steady state (Cavg), After the last dose on day 28 up to day 43|Terminal half-life of the analyte in plasma at steady state (t1/2,ss), After the last dose on day 28 up to day 43|Terminal rate constant in plasma at steady state (λz,ss), After last dose on day 28 up to day 43|Mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss), After last dose on day 28 up to day 43|Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss), After last dose on day 28 up to day 43|Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss), After last dose on day 28 up to day 43|Predose concentration of the analyte in plasma (Cpre) at different time points immediately before administration of the Nth dose, Up to day 28|Calculation of accumulation ratio of the analyte in plasma based on Cmax (RA,Cmax), Up to day 43|Calculation of accumulation ratio of the analyte in plasma based on AUCτ (RA,AUCτ), Up to day 43|Minimum dipeptidyl peptidase IV (DPP-IV) activity (Emin) at different time points, Up to day 43|Time to reach minimum DPP-IV activity (tmin) at different time points, Up to day 43|DPP-IV activity at different time points, Up to day 43
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