Influence of a High Fat Breakfast in the Pharmacokinetics of UH-AC62MU in Healthy Subjects

Study Overview
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Brief Summary
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Influence of a high fat breakfast in the pharmacokinetic profile of the 7.5 mg meloxicam rapid releases tablet

Official Title
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Influence of a High Fat Breakfast in the Pharmacokinetics of UH-AC62MU (Rapid Release Tablet) Given as an Oral Single Dose of 7.5 mg in Healthy Subjects (Two Way, Crossover, Randomized, Open)

Conditions
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Healthy

Intervention / Treatment
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* Drug: meloxicam rapid release tablet, 12mg, UH AC62MU


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 according good clinical practice (GCP) and local legislation Age >=18 and <=50 years Broca >= -20% and <= +20% Exclusion Criteria: Any finding of the medical examination (blood pressure, pulse rate and electrocardiogram (ECG)) deviating from the normal and of clinical relevance Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder Surgery of gastro-intestinal tract (except appendectomy) Disease of central nervous system (such as epilepsy) or psychiatric disorders or neurological disorder History of orthostatic hypotension, fainting spells or blackouts Chronic or relevant acute infections History of allergy/hypersensitivity (including drug allergy) which deemed relevant to the trial as judged by the investigator Intake of drugs with a long half-life ( >24h) (<=1month prior to administration) 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) Smokers ( >10 cigarettes or >3 cigars or >3 pipes/day) Inability to refrain from smoking on trial days Alcohol abuse (>60g/day) Drug abuse Blood donation (<= 1 month prior to administration or during the trial) Excessive physical activities (<= 5 days prior to administration or during the trial) Any laboratory value outside the reference range of clinical relevance History of hemorrhagic diatheses History of gastro-intestinal ulcer, perforation or bleeding History of bronchial asthma For female: 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 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 |
| --- | --- |
| Active Comparator: meloxicam rapid release tablet after an overnight fast<br> | Drug: meloxicam rapid release tablet, 12mg, UH AC62MU<br> <br> |
| Experimental: meloxicam rapid release tablet after high fat breakfast<br> | Drug: meloxicam rapid release tablet, 12mg, UH AC62MU<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 and up to 96 hours after drug administration | 
| Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC 0-infinity) |  | predose and up to 96 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achieve Cmax (tmax) |  | predose and up to 96 hours after drug administration | 
| Area under the concentration-time curve of the analyte in plasma from time zero to t (AUC 0-t) |  | predose and up to 96 hours after drug administration | 
| Terminal rate constant in plasma (λz) |  | predose and up to 96 hours after drug administration | 
| Terminal half-life of the analyte in plasma (t1/2) |  | predose and up to 96 hours after drug administration | 
| Mean residence time of the analyte total (MRT tot) |  | predose and up to 96 hours after drug administration | 
| Apparent clearance of the analyte in plasma following extravascular administration (CL/F) |  | predose and up to 96 hours after drug administration | 
| Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F) |  | predose and up to 96 hours after drug administration | 
| Number of patients with abnormal changes in laboratory values |  | Baseline, 96 hours after drug administration | 
| Number of Participants with Adverse Events |  | Up to day 5 after last drug administration | 
| Number of patients with abnormal changes from baseline in ECG |  | Baseline, day 5 after last drug administration | 
| Number of patients with abnormal changes from baseline in physical examination |  | Baseline, day 5 after last drug administration |