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Study to assess the effect of food on the pharmacokinetics of meloxicam after a single p.o. administration of 22.5 mg meloxicam oral suspension and to investigate dose-proportionality over a dosage range of 7.5 mg to 22.5 mg
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam - low dose, fasted | Experimental |
| |
| Meloxicam - medium dose, fasted | Experimental |
| |
| Meloxicam - high dose, fasted | Experimental |
| |
| Meloxicam - high dose, fed | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam - low dose | Drug |
| ||
| Meloxicam - medium dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 96 hours after drug administration | |
| AUC0-infinity (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 96 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) | up to 96 hours after drug administration | |
| AUC0-tf (Total area under the plasma drug concentration-time curve (AUC) from time of administration (0) to the last quantifiable drug concentration) |
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Inclusion Criteria:
Exclusion Criteria:
For female subjects:
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| Drug |
|
| Meloxicam - high dose | Drug |
|
| up to 96 hours after drug administration |
| t½ (Terminal half-life of the analyte in plasma) | up to 96 hours after drug administration |
| Terminal rate constant in plasma | up to 96 hours after drug administration |
| CL/F (Apparent clearance of the analyte in plasma following extravascular administration) | up to 96 hours after drug administration |
| Vz/F (Apparent volume of distribution of the analyte during the terminal phase) | up to 96 hours after drug administration |
| MRTtot (Total mean residence time) | up to 96 hours after drug administration |
| Number of patients with adverse events | up to 10 weeks |
| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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