Study of Relative Bioavailability of Mobic Manufactured in China in Comparison With Mobic Manufactured in Germany in Chinese Healthy Volunteers

Study Overview
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Brief Summary
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The objective of this study is to compare the pharmacokinetic parameters of the 7.5 mg Mobic tablet manufactured in china in comparison with 7.5 mg tablets manufactured in Germany

Official Title
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Relative Bioavailability of 7.5 mg Mobic Tablet Manufactured in China in Comparison With 7.5 mg Tablets Manufactured in Germany After a Single Oral Dose in Chinese Healthy Volunteers, Open, Randomized, Two Way Crossover Trial

Conditions
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Healthy

Intervention / Treatment
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* Drug: Mobic, China, 7.5 mg
* Drug: Mobic, Germany, 7.5 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chinese healthy male volunteers as determined by result of screening Written informed consent in accordance with Good Clinical Practice (GCP) Age >= 18 and <= 40 years Broca > - 20% and < + 20% Exclusion Criteria: Any finding of the medical examination (blood pressure, pulse rate and Electrocardiogram (ECG) deviating from normal and of clinical relevance Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder 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 Mobic and/or non-steroidal anti-inflammatory drugs Intake any drugs within 1 month before randomization Participation in another trial with an investigational drug within the last 2 month or during the trial Smokers ( >= 10 cigarettes or >= 3 cigars or >= 3 pipes/day) or inability to refrain from smoking on study days Alcohol or drug abuse Blood donation within the last 1 month Excessive physical activities within the last 5 days History of hemorrhagic diatheses History of gastro-intestinal ulcer, perforation or bleeding History of bronchial asthma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

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: Mobic Germany<br> | Drug: Mobic, China, 7.5 mg<br> <br> Drug: Mobic, Germany, 7.5 mg<br> <br> |
| Experimental: Mobic China<br> | Drug: Mobic, China, 7.5 mg<br> <br> Drug: Mobic, Germany, 7.5 mg<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) |  | 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) |  | Up to 96 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achieve Cmax (tmax) |  | 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) |  | Up to 96 hours after drug administration | 
| Terminal rate constant in plasma (λ) |  | Up to 96 hours after drug administration | 
| Terminal half-life of the analyte in plasma (t1/2) |  | Up to 96 hours after drug administration | 
| Mean residence time of the analyte (MRT) |  | Up to 96 hours after drug administration | 
| Apparent clearance of the analyte in plasma following extravascular administration (CL/F) |  | Up to 96 hours after drug administration | 
| Apparent volume of distribution following extravascular administration (Vd/F) |  | Up to 96 hours after drug administration | 
| Number of patients with clinically relevant changes from baseline in laboratory values |  | Baseline, up to day 5 after last drug administration | 
| Number of Participants with Adverse Events |  | Up to day 5 after last drug administration | 
| Number of patients with clinically relevant changes from baseline in physical examination (pulse rate, systolic and diastolic blood pressure) |  | Baseline, up to day 5 after last drug administration | 
| Global assessment of tolerability by investigator on a 4-point scale |  | Day 5 after last drug administration |