Pharmacokinetics and Tolerability of Meloxicam Injected Intramuscularly vs. Tablet in Healthy Subjects

Study Overview
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Brief Summary
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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

Official Title
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Pharmacokinetics and Tolerability of a Single 15mg Meloxicam Dose Injected Intramuscularly Compared to a Single Oral 15 mg Meloxicam Tablet in Healthy Subjects. A Two-way Cross-over, Randomized, Open Study.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Meloxicam ampoule
* Drug: Meloxicam tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects as determined by results of screening Written informed consent in accordance with Good Clinical Practice and local legislation Age ≥ 18 and ≤ 50 years Broca > - 20% and < + 20% 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: Pregnancy Positive pregnancy test No adequate contraception e.g. sterilization, IUD (intrauterine device), oral contraceptives Inability to maintain this adequate contraception during the whole study period Lactation period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meloxicam ampoule<br> | Drug: Meloxicam ampoule<br> <br> |
| Active Comparator: Meloxicam tablet<br> | Drug: Meloxicam tablet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |