| Outcome Measures: |
Primary: Area under the curve over the time (AUC), No statistical analysis will be performed, pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose|AUC from time zero to the time of last quantifiable analyte concentration (AUC(0-t)), No statistical analysis will be performed, pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose|Maximum concentration (Cmax), No statistical analysis will be performed, pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose | Secondary: Time to reach maximum analyte concentration (tmax), No statistical analysis will be performed, pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose|Terminal rate constant (λz), No statistical analysis will be performed, pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose|Time of last quantifiable analyte concentration (tlast), No statistical analysis will be performed, pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose|Terminal half-life (t1/2), No statistical analysis will be performed, pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose|Observed maximum analyte concentration (Cmax), No statistical analysis will be performed, pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose|Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC), No statistical analysis will be performed, pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose|Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUC(0 t)), No statistical analysis will be performed, pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose|Elimination terminal half-life (t1/2), No statistical analysis will be performed, pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose|Safety profile description in term of Adverse Events, No statistical analysis will be performed, from first dose in treatment period 1 up to 10 days after final dose|Safety profile description in term of Blood Pressure, No statistical analysis will be performed, at screening, once daily during the residential period (5 days each) and up to 10 days after final dose|Safety profile description in term of Physical Examination, No statistical analysis will be performed, at screening, Day -1 and Day 4 at Visits 2 to 5 and up to 10 days after final dose|Safety profile description in term of Electrocardiogram ECG, No statistical analysis will be performed, at screening and up to 10 days after final dose|Safety profile description in term of Heart Rate, No statistical analysis will be performed, at screening, once daily during the residential period (5 days each) and up to 10 days after final dose|Safety profile description in term of Safety Labs, No statistical analysis will be performed, at screening, on Day -1 and Day 4 (72 hours post-dose) at Visits 2 to 5 and up to 10 days after final dose
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