Study to investigate the relative bioavailability of ambroxol hydrochloride soft pastilles 15 mg vs. ambroxol hydrochloride (HCL) 15 mg of syrup (15mg/5mL, Reference I) and ambroxol hydrochloride 15 mg of syrup (30mg/5mL, Reference II) in a fasted state
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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 30 hours after each drug administration
Cmax (maximum concentration of the analyte in plasma)
Time frame: up to 30 hours after each drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 30 hours after each drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 30 hours after each drug administration
λz (terminal rate constant in plasma)
Time frame: up to 30 hours after each drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 30 hours after each drug administration
MRTpo (mean residence time of the analyte in the body after p.o. (oral) administration)
Time frame: up to 30 hours after each drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 30 hours after each drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 30 hours after each drug administration
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Number of patients with adverse events
Time frame: up to 40 days
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 40 days
Number of patients with clinically significant changes in vital signs (BP (Blood pressure), PR (Pulse rate))
Time frame: up to 40 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: within 8 days after last administration