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Influence of a high fat breakfast in the pharmacokinetic profile of the 7.5 mg meloxicam rapid releases tablet
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| meloxicam rapid release tablet after an overnight fast | Active Comparator |
| |
| meloxicam rapid release tablet after high fat breakfast | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| meloxicam rapid release tablet, 12mg, UH AC62MU | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum measured concentration of the analyte in plasma (Cmax) | predose and up to 96 hours after drug administration | |
| Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC 0-infinity) | predose and up to 96 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve Cmax (tmax) | predose and up to 96 hours after drug administration | |
| Area under the concentration-time curve of the analyte in plasma from time zero to t (AUC 0-t) | predose and up to 96 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
For female:
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| Terminal rate constant in plasma (λz) | predose and up to 96 hours after drug administration |
| Terminal half-life of the analyte in plasma (t1/2) | predose and up to 96 hours after drug administration |
| Mean residence time of the analyte total (MRT tot) | predose and up to 96 hours after drug administration |
| Apparent clearance of the analyte in plasma following extravascular administration (CL/F) | predose and up to 96 hours after drug administration |
| Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F) | predose and up to 96 hours after drug administration |
| Number of patients with abnormal changes in laboratory values | Baseline, 96 hours after drug administration |
| Number of Participants with Adverse Events | Up to day 5 after last drug administration |
| Number of patients with abnormal changes from baseline in ECG | Baseline, day 5 after last drug administration |
| Number of patients with abnormal changes from baseline in physical examination | Baseline, day 5 after last drug administration |