Preliminary Bioequivalence Study of UHAC 62 XX Tablets Compared With a Capsule Formulation in Healthy Male Volunteers

Study Overview
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Brief Summary
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Study to investigate the relative bioavailability of UHAC 62 XX capsule and two different tablet formulations (TF1 and TF2), and to obtain data for rational design of a subsequent pivotal bioequivalence (BE) study between capsule and tablet formulations.

Official Title
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Preliminary Bioequivalence Study of UHAC 62 XX Tablets Compared With a Capsule Formulation

Conditions
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Healthy

Intervention / Treatment
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* Drug: UHAC 62 XX - TF1 tablet
* Drug: UHAC 62 XX - TF2 tablet
* Drug: UHAC 62 XX - capsules


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 meloxicam and/or salicylate (aspirin) and/or Non-steroidal anti-inflammatory drugs (NSAIDs) History of aspirin induced asthma (bronchial asthma induced by NSAIDs) History of alcohol or drug abuse Participation to another trial with an investigational drug within 4 months prior to the administration Whole blood donation more than 400 ml within 3 months prior to the administration 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 administration Any medication within 10 days prior to the administration Excessive physical activities within 7 days prior to the administration Alcohol drinking within 3 days prior to the administration 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 TF1 tablet<br> | Drug: UHAC 62 XX - TF1 tablet<br> <br> Drug: UHAC 62 XX - TF2 tablet<br> <br> Drug: UHAC 62 XX - capsules<br> <br> |
| Experimental: UHAC 62 XX TF2 tablet<br> | Drug: UHAC 62 XX - TF1 tablet<br> <br> Drug: UHAC 62 XX - TF2 tablet<br> <br> Drug: UHAC 62 XX - capsules<br> <br> |
| Active Comparator: UHAC 62 XX capsule<br> | Drug: UHAC 62 XX - TF1 tablet<br> <br> Drug: UHAC 62 XX - TF2 tablet<br> <br> Drug: UHAC 62 XX - capsules<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (Maximum observed concentration in plasma) |  | up to 72 hours after administration | 
| AUC 0-72hr (Area under the concentration-time curve in plasma from zero time to 72 hours) |  | up to 72 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax (Time to reach maximum concentration) |  | up to 72 hours after administration | 
| t1/2 (Terminal half-life in plasma) |  | up to 72 hours after administration | 
| AUC 0-infinity (Area under the concentration-time curve in plasma from zero time to infinity) |  | up to 72 hours after administration | 
| MRT 0-t (Mean residence time in the body from zero time to the time of the last quantifiable drug concentration) |  | up to 72 hours after administration | 
| Number of patients with adverse events |  | up to 14 days after last administration |