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Study to assess the relative bioavailability of two 7.5 mg meloxicam tablets (American type) compared to one 15 mg meloxicam tablet (American type), and to investigate dose-proportionality over the dosage range 7.5 mg to 15 mg
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam low dose - one tablet | Experimental |
| |
| Meloxicam high dose - two tablets | Experimental |
| |
| Meloxicam high dose - one tablet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment 1 | Drug |
| ||
| Treatment 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum measured concentration of the analyte in plasma (Cmax) | predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose | |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Time from dosing to the maximum concentration of the analyte in plasma (tmax) | predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose | |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
For female subjects:
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|
| Treatment 3 | Drug |
|
| predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose |
| Apparent terminal elimination rate constant (λz ) | predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose |
| Terminal half-life of the analyte in plasma (t½) | predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose |
| Mean residence time (MRTtot) | predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose |
| Apparent clearance of the analyte in plasma following extravascular administration (CL/F) | predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose |
| Apparent volume of distribution of the analyte during the terminal phase (Vz/F) | predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose |
| Number of patients with abnormal findings in pulse rate | predose, up to 96:00 h post dose |
| Number of patients with abnormal findings in systolic and diastolic blood pressure | predose, up to 96:00 h post dose |
| Number of patients with adverse events | up to 39 days |
| Number of patients with abnormal changes in laboratory parameters | predose, up to 96:00 h post dose |