Study to investigate the relative bioavailability of a 20 mg ambroxol hydrochloride lozenge compared to 30 mg ambroxol hydrochloride syrup (Mucosolvan®) after dose normalisation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Cmax (Maximum observed concentration of the analyte in plasma)
Time frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
Tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
AUC0-t (Total area under the plasma concentration-time curve from time of administration to the last quantifiable drug concentration)
Time frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
λz (Terminal rate constant in Plasma)
Time frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
t½ (Terminal half-life of the analyte in plasma)
Time frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
MRTtot (Total mean residence time )
Time frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Time frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Time frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
Number of patients with adverse events
Time frame: up to 26 days
Number of patients with clinically significant changes in vital signs
Time frame: up to 26 days
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 26 days