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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambroxol hydrochloride - soft pastille | Experimental |
| |
| Ambroxol hydrochloride - syrup - low dose | Active Comparator |
| |
| Ambroxol hydrochloride - syrup - high dose | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambroxol hydrochloride - soft pastille | Drug |
| ||
| Ambroxol hydrochloride - syrup - low dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 30 hours after each drug administration | |
| Cmax (maximum concentration of the analyte in plasma) | up to 30 hours after each drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 30 hours after each drug administration | |
| tmax (time from dosing to the maximum concentration of the analyte in plasma) |
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Inclusion Criteria:
Exclusion Criteria:
For female subjects:
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| Drug |
|
| Ambroxol hydrochloride - syrup - high dose | Drug |
|
| up to 30 hours after each drug administration |
| λz (terminal rate constant in plasma) | up to 30 hours after each drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | up to 30 hours after each drug administration |
| MRTpo (mean residence time of the analyte in the body after p.o. (oral) administration) | up to 30 hours after each drug administration |
| CL/F (apparent clearance of the analyte in the plasma after extravascular administration) | up to 30 hours after each drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 30 hours after each drug administration |
| Number of patients with adverse events | up to 40 days |
| Number of patients with abnormal changes in laboratory parameters | up to 40 days |
| Number of patients with clinically significant changes in vital signs (BP (Blood pressure), PR (Pulse rate)) | up to 40 days |
| Assessment of tolerability by investigator on a 4-point scale | within 8 days after last administration |