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Study to investigate the relative bioavailability of a 20 mg ambroxol hydrochloride lozenge compared to 30 mg ambroxol hydrochloride syrup (Mucosolvan®) after dose normalisation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambroxol hydrochloride - lozenge | Experimental |
| |
| Ambroxol hydrochloride - syrup | Active Comparator | Mucosolvan® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambroxol hydrochloride - lozenge | Drug |
| ||
| Ambroxol hydrochloride - syrup |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum observed concentration of the analyte in plasma) | 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) | predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax (Time from dosing to the maximum concentration of the analyte in plasma) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
For female subjects:
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| Drug |
|
| 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) | 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) | 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 ) | 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) | predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose |
| Vz/F (Apparent volume of distribution of the analyte during the terminal phase) | 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 | up to 26 days |
| Number of patients with clinically significant changes in vital signs | up to 26 days |
| Number of patients with abnormal changes in laboratory parameters | up to 26 days |