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Study to investigate the bioequivalence of UH-AC 62 XX tablets 10 mg (TF4) and UH-AC 62 XX capsules 10 mg by single administration in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UH-AC 62 XX tablet | Experimental |
| |
| UH-AC 62 XX capsule | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UH-AC 62 XX tablet | Drug |
| ||
| UH-AC 62 XX capsule |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum observed concentration of the analyte in plasma) | up to 60 hours after drug administration | |
| AUC 0-60hr (Area under the concentration time curve of the analyte in plasma from zero time to 60 hours) | up to 60 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax (Time to reach Cmax) | up to 60 hours after drug administration | |
| t1/2 ( Terminal half-life of the analyte in plasma) | up to 60 hours after drug administration | |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| AUC 0-infinity (Area under the concentration time curve of the analyte in plasma from zero time to infinity) |
| up to 60 hours after drug administration |
| MRTpo (Mean residence time of the analyte in the body after single dose po administration) | up to 60 hours after drug administration |
| Number of patients with adverse events | up to 20 days after final drug administration |