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Study to investigate the pharmacokinetics and tolerability of an intramuscular 15 mg meloxicam injection in comparison to the 15 mg oral tablet
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam ampoule | Experimental |
| |
| Meloxicam tablet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam ampoule | Drug |
| ||
| Meloxicam tablet |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf (total area under the plasma drug concentration-time curve) | up to 96 hours after drug administration | |
| Cmax (Maximum drug plasma concentration) | up to 96 hours after drug administration | |
| tmax (Time to achieve Cmax) | up to 96 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t (Total area under the plasma drug concentration-time curve from time of administration to the time of the last quantifiable drug concentration) | up to 96 hours after drug administration | |
| λz (apparent terminal elimination rate constant) | up to 96 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
Any findings of the medical examination (including laboratory, blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastro-intestinal tract ( except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
Chronic or relevant acute infections
Hypersensitivity to meloxicam and/or non-steroidal antirheumatic agents
Intake of drugs with a long half-life (>24 hours) (≤ 1 month prior to administration or during the trial)
Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial)
Smoker (>= 10 cigarettes or >= 3 cigars or >= 3 pipes/day)
Inability to refrain from smoking on study days
Known alcohol abuse
Known drug abuse
Blood donation (≤ 1 month prior to administration)
Excessive physical activities (≤ 5 days prior to administration)
History of hemorrhagic diatheses
History of gastro-intestinal ulcer, perforation or bleeding
History of bronchial asthma
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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|
| t1/2 (apparent terminal elimination half-life) | up to 96 hours after drug administration |
| MRTtot (Mean residence time) | up to 96 hours after drug administration |
| CL/f (Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration) | up to 96 hours after drug administration |
| Vz/f (Apparent volume of distribution during the terminal phase λz following extravascular administration) | up to 96 hours after drug administration |
| Change from baseline in vital signs (pulse rate, systolic and diastolic blood pressure) | Baseline, days 1-5 of each treatment period |
| Change from baseline in laboratory parameters | Baseline, days 1-2 and 5 of each treatment period |
| Number of patients with adverse events | up to 72 hours after day 5 of each treatment period |
| Tolerability of the intramuscular injection | before and 4 and 24 hours after application of study drug |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |