Effect of Food on the Pharmacokinetics of Meloxicam in Healthy Volunteers

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

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% Written informed consent in accordance with Good Clinical Practice and local legislation Exclusion Criteria: Any finding of the medical examination (including blood pressure, pulse rate and ECG and laboratory value) deviating from normal and of clinical relevance Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders Surgery of the gastro-intestinal tract (except appendectomy) Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders History of orthostatic hypotension, fainting spells and 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 1 month or less than ten half-lives of the respective drug prior to administration Use of any drugs which might influence the results of the trial (≤ one week prior to administration or during trial) Participation in another trial with an investigational drug within 2 months prior to administration or during trial Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) Inability to refrain from smoking on study days Alcohol abuse (> 60 g/day) Drug abuse Blood donation (≥ 100 mL within 4 weeks prior to administration or during the trial) Excessive physical activities (within the last week before the study) Any laboratory value outside the reference range or 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, fed<br> | Drug: Meloxicam, high dose<br> <br> |
| Active Comparator: Meloxicam high dose, fasted<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 |
| --- | --- | --- |
| Maximum drug plasma concentration (Cmax) |  | up to 96 hours after drug administration | 
| Total area under the plasma concentration-time curve from time to administration to infinity (AUC0-infinity) |  | up to 96 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to maximum concentration (Tmax) |  | up to 96 hours after drug administration | 
| Total area under the plasma drug concentration-time curve from time of administration to the last quantifiable drug (AUC0-tf) |  | up to 96 hours after drug administration | 
| Apparent terminal elimination rate constant (λz) |  | up to 96 hours after drug administration | 
| Apparent terminal half-life (t1/2) |  | up to 96 hours after drug administration | 
| Mean total residence time (MRTtot) |  | up to 96 hours after drug administration | 
| Total clearance, divided by f (CL/f) |  | up to 96 hours after drug administration | 
| Apparent volume of distribution during the terminal phase, divided by f (Vz/f) |  | up to 96 hours after drug administration | 
| Number of patients with adverse events |  | up to 67 days |