Pharmacokinetics and Tolerability of Meloxicam Gel Compared to Meloxicam Tablets in Healthy Subjects

Study Overview
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Brief Summary
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Study to gain information on the percutaneous absorption of meloxicam after administration of a topical gel over 7 days.

Official Title
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Pharmacokinetics and Tolerability of 2 x 15 mg Meloxicam (2 x 0.3 g Topical Gel) Over 7 Days Compared to 7.5 mg Meloxicam Tablet (Single Oral Dose) 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 gel
* 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 Signed 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 blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Surgery of the gastrointestinal tract (except appendectomy) Diseases of the central nervous system (such as epilepsy) or psychiatric disorders Chronic or relevant acute infections Hypersensitivity to meloxicam and any of the excipients 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 months prior to administration) Excessive physical activities (<= 5 days prior to administration) History of hemorrhagic diatheses History of gastrointestinal ulcer, perforation or bleeding History of bronchial asthma Any laboratory value outside the normal range of clinical relevance History of dermatological diseases Skin disease and/or skin lesions at the site of planned application For female subjects: Pregnancy Positive pregnancy test Breast feeding

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 gel<br> | Drug: Meloxicam gel<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 |
| --- | --- | --- |
| Analysis of plasma concentration-time course after topical dose |  | up to 264 hours after first topical administration | 
| Determination of the ratio AUCss topical/AUC0-∞ oral |  | up to 96 hours after oral administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum measured concentration of the analyte in plasma (Cmax) |  | up to 96 hours after oral administration | 
| Time from dosing to the maximum concentration of the analyte in plasma (Tmax) |  | up to 96 hours after oral administration | 
| 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) |  | up to 96 hours after oral administration | 
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) |  | up to 96 hours after oral administration | 
| Terminal half-life of the analyte in plasma (t½) |  | up to 96 hours after oral administration | 
| Apparent terminal elimination rate constant |  | up to 96 hours after oral administration | 
| Apparent clearance of the analyte in plasma following extravascular administration (CL/F) |  | up to 96 hours after oral administration | 
| Apparent volume of distribution of the analyte during the terminal phase (Vz/F) |  | up to 96 hours after oral administration | 
| Mean residence time (MRTtot) |  | up to 96 hours after oral administration | 
| Excretion of metabolites in urine |  | 0-24 hours after oral administration | 
| Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) |  | up to 264 hours after first topical administration | 
| Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss) |  | up to 264 hours after first topical administration | 
| Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) |  | up to 264 hours after first topical administration | 
| Total area under the plasma drug concentration time curve (AUC) during a steady state interval (AUCss) |  | up to 264 hours after first topical administration | 
| Terminal half-life of the analyte in plasma (t½) |  | up to 264 hours after first topical administration | 
| Apparent terminal elimination rate constant |  | up to 264 hours after first topical administration | 
| Occurence of adverse events |  | up to 24 days | 
| Assessment of local and systemic tolerability |  | up to 24 days |