Aim of this trial is to investigate the single dose pharmacokinetics and the effect of food on single dose of 160 mg 245 CL (two 80 mg tablets) as well as its safety
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 24 hours post dose
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 24 hours post dose
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 24 hours post dose
λz (Terminal rate constant in plasma)
Time frame: up to 24 hours post dose
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 24 hours post dose
MRTtot (Mean residence time)
Time frame: up to 24 hours post dose
Number of subjects with adverse events
Time frame: up to 20 days
Assessment of tolerability by investigator
Time frame: after 20 days
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