The main objectives of the present study are to determine pharmacokinetics of ambroxol in healthy male volunteers following repeated administration of lozenges of 20 mg ambroxol for four days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 24 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 24 hours after drug administration
AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours)
Time frame: up to 24 hours after drug administration
Ae0-24 (amount of the analyte that is eliminated in urine from the time point 0 until time point 24)
Time frame: up to 24 hours after drug administration
CLR,0-24 (renal clearance of the analyte determined from the time point 0 until time point 24) using AUC0-24 and Ae0-24
Time frame: up to 24 hours after drug administration
Cmax,ss (maximum concentration of the analyte in plasma at steady state)
Time frame: up to 120 hours after first drug administration
tmax,ss (time from last dosing to maximum concentration at steady state)
Time frame: up to 120 hours after first drug administration
Cmin,ss (minimum concentration of the analyte in plasma at steady state)
Time frame: up to 120 hours after first drug administration
AUC72-96,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform 24 hour interval matching Day 1)
Time frame: up to 96 hours after first drug administration
Ae72-96,ss (amount of analyte that is eliminated in urine at steady state from the time point 72 to time point 96)
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Time frame: up to 96 hours after first drug administration
CLR,72-96,ss (renal clearance of the analyte in plasma from the time point 72 until the time point 96 at steady state) using AUC72-96 and Ae72-96
Time frame: up to 96 hours after first drug administration
λz,ss (terminal rate constant in plasma at steady state)
Time frame: up to 120 hours after first drug administration
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time frame: up to 120 hours after first drug administration
RA (accumulation ratio)
Time frame: up to 96 hours after first drug administration
LI (linearity index)
Time frame: up to 96 hours after first drug administration
Number of patients with adverse events
Time frame: up to 36 days
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 36 days
Number of patients with clinically significant changes in vital signs (blood pressure [BP], pulse rate [PR])
Time frame: up to 36 days
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
Time frame: up to 36 days
Assessment of tolerability on a 4-point scale
Time frame: 10 days after last drug administration