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Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules (reference drug) of meloxicam (UHAC 62 XX) after 7-day administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UHAC 62 XX tablet | Experimental |
| |
| UHAC 62 XX capsule | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UHAC 62 XX tablet | Drug |
| ||
| UHAC 62 XX capsule |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum observed concentration of the analyte in plasma) | up to day 8 | |
| AUC 0-τ (Area under the concentration time curve in plasma from zero time to 24 hours after 7-day administration) | up to day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax (Time to reach Cmax) | up to day 8 | |
| T1/2 (Terminal half-life in plasma) | up to day 8 | |
| MRT 0-τ (Mean residence time in the body after 7-day administration) |
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Inclusion Criteria:
Exclusion Criteria:
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|
| up to day 8 |
| Cτ (Concentration of the analyte in plasma 24 hours after 7-day administration) | up to day 8 |
| Number of patients with adverse events | up to 20 days after final administration |