Bioequivalence Study of UHAC 62 XX Tablets Compared With Capsules in Healthy Volunteers

Study Overview
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Brief Summary
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Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules (reference drug) of meloxicam (UHAC 62 XX) in fasted state.

Official Title
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Bioequivalence Study of UHAC 62 XX 10 mg Tablets Compared With 10 mg Capsules Following Single Peroral Administration in Healthy Volunteers (An Open-label, Randomised, Two-way Crossover Study)

Conditions
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Healthy

Intervention / Treatment
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* Drug: UHAC 62 XX tablet
* Drug: UHAC 62 XX capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 20 and <= 35 years Weight: BMI >= 18.5 and < 25 (Weight (kg) / Height (m²) Subjects who are judged by the investigator to be appropriate as the subjects of the study based on results of screening test Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent Exclusion Criteria: History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy) History of hypersensitivity to UHAC 62 XX and/or salicylate (aspirin) and/or Non-steroidal anti-inflammatory drugs (NSAIDs) History of aspirin induced asthma (bronchial asthma induced by NSAIDs) History of bleeding tendency History of alcohol or drug abuse Participation to another trial with an investigational drug within 4 months prior to the trial Whole blood donation more than 400 ml within 3 months prior to the trial Whole blood donation more than 100 ml within 1 month prior to the administration Donation of constituent of blood of more than 400 ml within 1 month prior to the trial Any medication which might influence the results of the trial within 10 days prior to the trial Excessive physical activities within 7 days prior to the trial Alcohol drinking within 3 days prior to the trial History of orthostatic hypotension, fainting spells or blackouts Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 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 |
| --- | --- |
| Experimental: UHAC 62 XX tablet<br> | Drug: UHAC 62 XX tablet<br> <br> Drug: UHAC 62 XX capsule<br> <br> |
| Active Comparator: UHAC 62 XX capsule<br> | Drug: UHAC 62 XX tablet<br> <br> Drug: UHAC 62 XX capsule<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (Maximum observed concentration of the analyte in plasma) |  | up to 60 hours after drug administration | 
| AUC 0-60hr (Area under the concentration time curve of the analyte in plasma from zero time to 60 hours) |  | up to 60 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax (Time to reach Cmax) |  | up to 60 hours after drug administration | 
| t1/2 ( Terminal half-life of the analyte in plasma) |  | up to 60 hours after drug administration | 
| AUC 0-infinity (Area under the concentration time curve of the analyte in plasma from zero time to infinity) |  | up to 60 hours after drug administration | 
| MRT 0-infinity (Mean residence time of the analyte molecules in the body from zero time to infinity) |  | up to 60 hours after drug administration | 
| Number of patients with adverse events |  | up to 20 days after final drug administration |