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Study to gain information on the percutaneous absorption of meloxicam after administration of a topical gel over 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam gel | Experimental |
| |
| Meloxicam tablet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam gel | Drug |
| ||
| Meloxicam tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of plasma concentration-time course after topical dose | up to 264 hours after first topical administration | |
| Determination of the ratio AUCss topical/AUC0-∞ oral | up to 96 hours after oral administration |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum measured concentration of the analyte in plasma (Cmax) | up to 96 hours after oral administration | |
| Time from dosing to the maximum concentration of the analyte in plasma (Tmax) | up to 96 hours after oral 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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|
| Total area under the plasma drug concentration time curve (AUC) from time of administration to the time of the last quantifiable drug concentration (AUC0-t) | up to 96 hours after oral administration |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | up to 96 hours after oral administration |
| Terminal half-life of the analyte in plasma (t½) | up to 96 hours after oral administration |
| Apparent terminal elimination rate constant | up to 96 hours after oral administration |
| Apparent clearance of the analyte in plasma following extravascular administration (CL/F) | up to 96 hours after oral administration |
| Apparent volume of distribution of the analyte during the terminal phase (Vz/F) | up to 96 hours after oral administration |
| Mean residence time (MRTtot) | up to 96 hours after oral administration |
| Excretion of metabolites in urine | 0-24 hours after oral administration |
| Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) | up to 264 hours after first topical administration |
| Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss) | up to 264 hours after first topical administration |
| Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) | up to 264 hours after first topical administration |
| Total area under the plasma drug concentration time curve (AUC) during a steady state interval (AUCss) | up to 264 hours after first topical administration |
| Terminal half-life of the analyte in plasma (t½) | up to 264 hours after first topical administration |
| Apparent terminal elimination rate constant | up to 264 hours after first topical administration |
| Occurence of adverse events | up to 24 days |
| Assessment of local and systemic tolerability | up to 24 days |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |