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The objective of this study is to compare the pharmacokinetic parameters of the 7.5 mg Mobic tablet manufactured in china in comparison with 7.5 mg tablets manufactured in Germany
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobic Germany | Active Comparator |
| |
| Mobic China | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobic, China, 7.5 mg | Drug |
| ||
| Mobic, Germany, 7.5 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum measured concentration of the analyte in plasma (Cmax) | 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) | Up to 96 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve Cmax (tmax) | 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) | Up to 96 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| Terminal rate constant in plasma (λ) | Up to 96 hours after drug administration |
| Terminal half-life of the analyte in plasma (t1/2) | Up to 96 hours after drug administration |
| Mean residence time of the analyte (MRT) | Up to 96 hours after drug administration |
| Apparent clearance of the analyte in plasma following extravascular administration (CL/F) | Up to 96 hours after drug administration |
| Apparent volume of distribution following extravascular administration (Vd/F) | Up to 96 hours after drug administration |
| Number of patients with clinically relevant changes from baseline in laboratory values | Baseline, up to day 5 after last drug administration |
| Number of Participants with Adverse Events | Up to day 5 after last drug administration |
| Number of patients with clinically relevant changes from baseline in physical examination (pulse rate, systolic and diastolic blood pressure) | Baseline, up to day 5 after last drug administration |
| Global assessment of tolerability by investigator on a 4-point scale | Day 5 after last drug administration |
| 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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