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Pharmacokinetics (relative bioavailability), safety and tolerability
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Experimental |
| |
| Brufen | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen syrup | Drug |
| ||
| Brufen syrup |
| Measure | Description | Time Frame |
|---|---|---|
| Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞) | Up to 12 hours after each administration | |
| Maximum drug plasma concentration (Cmax) | Up to 12 hours after each administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach the maximum concentration of the analyte in plasma (tmax) | Up to 12 hours after each administration | |
| Apparent terminal rate constant (λz) | Up to 12 hours after each administration | |
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Inclusion Criteria:
Exclusion Criteria:
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|
| Apparent terminal half-life of the analyte in plasma (t1/2) |
| Up to 12 hours after each administration |
| Total area under the plasma drug concentration-time curve from time zero to the last quantifiable drug (AUC0-t(last)) | Up to 12 hours after each administration |
| Mean residence time, total (MRTtot) | Up to 12 hours after each administration |
| Total plasma clearance divided by the systemic availability factor (CL/f) | Up to 12 hours after each administration |
| Volume of distribution during the terminal phase λz, divided by f (Vz/f) | Up to 12 hours after each administration |
| Number of adverse events | Up to 8 days after last drug administration |
| Change from baseline in 12-lead ECG (electrocardiogram) | Baseline, 8 days after last drug administration |
| Change in vital functions (blood pressure and puls rate) | Baseline, up to 8 days after last drug administration |
| Change from baseline in standard laboratory evaluation | Baseline, 8 days after last drug administration |