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To assess the bioequivalence of two galenic formulations for epinastine (Flurinol®): syrup and 20 mg tablets
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epinastine syrup | Experimental |
| |
| Epinastine tablets | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epinastine syrup | Drug |
| ||
| Epinastine tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of plasma concentration (CP) | Up to 24 hours after drug administration | |
| Absorption rate Cpmax/AUC | Up to 24 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cpmax) | Up to 24 hours after drug administration | |
| Time to peak (Tmax) | Up to 24 hours after drug administration | |
| Drug half - life (T1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C053090 | epinastine |
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|
| Up to 24 hours after drug administration |
| Number of participants with adverse events | Up to 24 hours after last drug administration |
| Number of participants withdrawn or discontinued due to safety reasons | Up to 24 hours after last drug administration |
| Number of participants with abnormal findings in physical examination | Up to 24 hours after last drug administration |
| Number of participants with clinically significant findings in vital signs | Up to 24 hours after last drug administration |