Relative Bioavailability of Meloxicam 2 x 7.5 mg Tablets Compared to 15 mg Tablet and Dose Proportionality Over a Dose Range of 7.5 mg and 15 mg in Healthy Volunteers

Study Overview
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Brief Summary
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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

Official Title
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An Open, Randomized, Three-way Cross-over Study in Healthy Volunteers to Evaluate the Relative Bioavailability of Meloxicam After Single p.o. Administration of 2 x 7.5 mg Meloxicam Tablets Compared to 15 mg Meloxicam Tablet, and Dose-proportionality Over a Dosage Range of 7.5 mg and 15 mg.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Treatment 1
* Drug: Treatment 2
* Drug: Treatment 3


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 (GCP) and local legislation Age >= 18 and <= 50 years Broca >= -20% and <= + 20 % Exclusion Criteria: Any finding of the medical examination (including laboratory blood pressure, pulse rate and 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 Alcohol abuse Drug abuse Blood donation (<= 1 months 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, intrauterine device (IUD), oral contraceptives Inability to maintain this adequate contraception during the whole study period Lactating

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 low dose - one tablet<br> | Drug: Treatment 1<br> <br> |
| Experimental: Meloxicam high dose - two tablets<br> | Drug: Treatment 2<br> <br> |
| Active Comparator: Meloxicam high dose - one tablet<br> | Drug: Treatment 3<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 |