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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bioequivalence Study of UHAC62XX Tablets Compared With Capsules in Healthy Volunteers

NCT02187575

Healthy

COMPLETED PHASE1

Bioequivalence Study of UH-AC 62 XX Tablets Compared With the Capsule Formulations in Healthy Volunteers

NCT02181907

Healthy

COMPLETED PHASE1

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

NCT02180477

Healthy

COMPLETED PHASE1

Bioequivalence Study of Meloxicam Capsules 15 mg (Mobic® Capsules 15 mg) Versus Meloxicam Tablets 15 mg (Mobic® Tablets 15 mg) in Healthy Adult Volunteers

NCT02183181

Healthy

COMPLETED PHASE1

Fasting Study of Meloxicam Tablets 15 mg and Mobic® Tablets 15 mg

NCT00649077

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

UHAC 62 XX tablet

Group Type EXPERIMENTAL

UHAC 62 XX tablet

Intervention Type DRUG

UHAC 62 XX capsule

Intervention Type DRUG

UHAC 62 XX capsule

Group Type ACTIVE_COMPARATOR

UHAC 62 XX tablet

Intervention Type DRUG

UHAC 62 XX capsule

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

UHAC 62 XX tablet

Intervention Type DRUG

UHAC 62 XX capsule

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes