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Study to investigate dose-proportionality over the dosage range 7.5 mg to 22.5 mg, and to assess the effect of food on the pharmacokinetics of meloxicam after a single p.o. administration of 22.5 mg meloxicam oral suspension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam low dose, fasted | Experimental |
| |
| Meloxicam medium dose, fasted | Experimental |
| |
| Meloxicam high dose, fed | Experimental |
| |
| Meloxicam high dose, fasted | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam, low dose | Drug |
| ||
| Meloxicam, medium dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum drug plasma concentration (Cmax) | up to 96 hours after drug administration | |
| Total area under the plasma concentration-time curve from time to administration to infinity (AUC0-infinity) | up to 96 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum concentration (Tmax) | up to 96 hours after drug administration | |
| Total area under the plasma drug concentration-time curve from time of administration to the last quantifiable drug (AUC0-tf) | up to 96 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
For female subjects:
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
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| Drug |
|
| Meloxicam, high dose | Drug |
|
| Apparent terminal elimination rate constant (λz) | up to 96 hours after drug administration |
| Apparent terminal half-life (t1/2) | up to 96 hours after drug administration |
| Mean total residence time (MRTtot) | up to 96 hours after drug administration |
| Total clearance, divided by f (CL/f) | up to 96 hours after drug administration |
| Apparent volume of distribution during the terminal phase, divided by f (Vz/f) | up to 96 hours after drug administration |
| Number of patients with adverse events | up to 67 days |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |