Study to Assess the Effect of Food on the Pharmacokinetics of Meloxicam After Single Administration and to Investigate Dose-proportionality Over a Dosage Range

Study Overview
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Brief Summary
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Study to assess the effect of food on the pharmacokinetics of meloxicam after a single p.o. administration of 22.5 mg meloxicam oral suspension and to investigate dose-proportionality over a dosage range of 7.5 mg to 22.5 mg

Official Title
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An Open, Randomised, Four-way Crossover Study in Healthy Volunteers to Evaluate the Effect of Food on the Pharmacokinetics of Meloxicam After a Single p.o. Administration of 22.5 mg Meloxicam Oral Suspension and Dose-proportionality Over a Dosage Range of 7.5 mg to 22.5 mg.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Meloxicam - low dose
* Drug: Meloxicam - medium dose
* Drug: Meloxicam - high dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female subjects as determined by results of screening Age range from 21 to 50 years Broca-Index +- 20% In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study Exclusion Criteria: Any finding of the medical examination (including 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) Disease of the central nervous system (such a epilepsy) or psychiatric disorders or neurological disorders History of orthostatic hypotension, fainting spells or blackouts Chronic or relevant acute infections History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study Use of any drugs which might influence the results of the trial (<= one week prior to administration or during the trial) Participation in another trial with an investigational drug (<= two months prior to administration or during the trial) Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day) Inability to refrain from smoking on trial days Alcohol abuse (> 60 g/day) Drug abuse Blood donation (>= 100 mL within four weeks prior to administration or during the trial Excessive physical activities (within the last week before study) Anl laboratory value outside the reference range of clinical relevance History of haemorrhagic diatheses History of gastrointestinal ulcer, perforation or bleeding History of bronchial asthma For female subjects: Pregnancy Positive pregnancy test No adequate contraception e.g sterilisation, intrauterine pessary, oral contraceptives Inability to maintain this adequate contraception during the whole study period Lactating

Ages Eligible for Study
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Minimum Age: 21 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, fasted<br> | Drug: Meloxicam - low dose<br> <br> |
| Experimental: Meloxicam - medium dose, fasted<br> | Drug: Meloxicam - medium dose<br> <br> |
| Experimental: Meloxicam - high dose, fasted<br> | Drug: Meloxicam - high dose<br> <br> |
| Experimental: Meloxicam - high dose, fed<br> | Drug: Meloxicam - high dose<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (Maximum measured concentration of the analyte in plasma) |  | up to 96 hours after drug administration | 
| AUC0-infinity (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |  | up to 96 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) |  | up to 96 hours after drug administration | 
| AUC0-tf (Total area under the plasma drug concentration-time curve (AUC) from time of administration (0) to the last quantifiable drug concentration) |  | up to 96 hours after drug administration | 
| t½ (Terminal half-life of the analyte in plasma) |  | up to 96 hours after drug administration | 
| Terminal rate constant in plasma |  | up to 96 hours after drug administration | 
| CL/F (Apparent clearance of the analyte in plasma following extravascular administration) |  | up to 96 hours after drug administration | 
| Vz/F (Apparent volume of distribution of the analyte during the terminal phase) |  | up to 96 hours after drug administration | 
| MRTtot (Total mean residence time) |  | up to 96 hours after drug administration | 
| Number of patients with adverse events |  | up to 10 weeks |