| Outcome Measures: |
Primary: Assessment of tolerability by investigator on a 4-point scale, Day 50|Incidence of adverse events, up to 50 days|Number of patients with abnormal changes in clinical laboratory parameters, Baseline, up to day 50 | Secondary: Cmax (maximum concentration of the analyte in plasma), before and up to 43 days after first study drug administration|tmax (time from dosing to maximum concentration), before and up to 43 days after first study drug administration|AUC (area under the concentration-time curve of the analyte in plasma) for several time points, before and up to 43 days after first study drug administration|Cmax,ss (maximum concentration of the analyte in plasma at steady state over a uniform dosing interval), before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration|Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval), before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration|Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N), pre-dose on day 28|tmax,ss (time from dosing to maximum concentration at steady state), before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration|AUCτ,ss (area under the concentration time curve of the analyte in plasma at steady state over a uniform dosing interval), before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration|λz,ss (terminal rate constant in plasma at steady state), before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration|t1/2,ss (terminal half-life of the analyte in plasma at steady state), before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration|MRTpo,ss (mean residence time of the analyte in the body after 12 administrations at steady state), before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration|CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state), before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration|Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state), before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration|PTF (peak trough fluctuation), before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration|Accumulation ratio (RA) based on Cmax, up to 28 days|RA,AUC based on AUCτ, up to 28 days|Dipeptidyl-Peptidase IV (DPP-IV) activity for several time points, up to day 43|Change in fasting plasma glucose (AUEC0-3) after MTT (meal tolerance test ), days -1, 1 and 29|Plasma glucose levels, up to day 43
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