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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UHAC 62 XX TF1 tablet

Group Type EXPERIMENTAL

UHAC 62 XX - TF1 tablet

Intervention Type DRUG

UHAC 62 XX - TF2 tablet

Intervention Type DRUG

UHAC 62 XX - capsules

Intervention Type DRUG

UHAC 62 XX TF2 tablet

Group Type EXPERIMENTAL

UHAC 62 XX - TF1 tablet

Intervention Type DRUG

UHAC 62 XX - TF2 tablet

Intervention Type DRUG

UHAC 62 XX - capsules

Intervention Type DRUG

UHAC 62 XX capsule

Group Type ACTIVE_COMPARATOR

UHAC 62 XX - TF1 tablet

Intervention Type DRUG

UHAC 62 XX - TF2 tablet

Intervention Type DRUG

UHAC 62 XX - capsules

Intervention Type DRUG

Interventions

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UHAC 62 XX - TF1 tablet

Intervention Type DRUG

UHAC 62 XX - TF2 tablet

Intervention Type DRUG

UHAC 62 XX - capsules

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes