Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study to investigate the relative bioavailability of orally administered dextromethorphan syrup in comparison to dextromethorphan (DMP) soft pastilles in healthy male and female subjects who are extensive metabolisers for CYP 2D6
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextromethorphan syrup | Experimental | Bisoltussin® Syrup |
|
| Dextromethorphan soft pastilles | Active Comparator | Silomat® DMP soft pastilles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextromethorphan syrup | Drug |
| ||
| Dextromethorphan soft pastilles |
| 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) - for dextromethorphan and dextrorphan (total and free) | predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration | |
| Cmax (maximum measured concentration of the analyte in plasma) - for dextromethorphan and dextrorphan (total and free) | predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration | |
| tmax (time from dosing to the maximum measured concentration of the analyte in plasma) - for dextromethorphan and dextrorphan (total and free) | predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after 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) - all analytes | predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration | |
| AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2) - all analytes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
For female subjects:
Exclusion criteria specific for this study:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration |
| %AUCtz-∞ (percentage of the AUC0-∞ that is obtained by extrapolation) - all analytes | predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration |
| λz (terminal rate constant in plasma) - all analytes | predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) - all analytes | predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration |
| MRTpo (mean residence time of the analyte in the body after oral administration) - all analytes | predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration |
| CL/F (apparent clearance of the analyte in the plasma after oral administration) - all analytes | predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose) - all analytes | predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration |
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) - 3-hydroxy-morphinan (total and free) and 3- methoxy-morphinan | predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration |
| Cmax (maximum measured concentration of the analyte in plasma) - 3-hydroxy-morphinan (total and free) and 3- methoxy-morphinan | predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration |
| tmax (time from dosing to the maximum measured concentration of the analyte in plasma) - 3-hydroxy-morphinan (total and free) and 3- methoxy-morphinan | predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration |
| Number of patients with adverse events | up to 53 days |
| Number of patients with abnormal changes in laboratory parameters | Screening, 14 days after the end of last treatment period |
| Number of patients with abnormal changes in 12-lead ECG (electrocardiogram) (including QT interval and heart rate corrected QTcF and QTcB) | Screening, Day 1, 14 days after the end of last treatment period |
| Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR)) | Screening, Day 1, 14 days after the end of last treatment period |
| Assessment of tolerability on a 4-point scale | Day 2 of each treatment period |