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Study to investigate the relative bioavailability of UHAC 62 XX capsule and two different tablet formulations (TF1 and TF2), and to obtain data for rational design of a subsequent pivotal bioequivalence (BE) study between capsule and tablet formulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UHAC 62 XX TF1 tablet | Experimental |
| |
| UHAC 62 XX TF2 tablet | Experimental |
| |
| UHAC 62 XX capsule | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UHAC 62 XX - TF1 tablet | Drug |
| ||
| UHAC 62 XX - TF2 tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum observed concentration in plasma) | up to 72 hours after administration | |
| AUC 0-72hr (Area under the concentration-time curve in plasma from zero time to 72 hours) | up to 72 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| tmax (Time to reach maximum concentration) | up to 72 hours after administration | |
| t1/2 (Terminal half-life in plasma) | up to 72 hours after administration | |
| AUC 0-infinity (Area under the concentration-time curve in plasma from zero time to infinity) |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| UHAC 62 XX - capsules | Drug |
|
| up to 72 hours after administration |
| MRT 0-t (Mean residence time in the body from zero time to the time of the last quantifiable drug concentration) | up to 72 hours after administration |
| Number of patients with adverse events | up to 14 days after last administration |