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

NCT ID: NCT02181907

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31

Brief Summary

Study to investigate the bioequivalence of UH-AC 62 XX tablets 10 mg (TF4) and UH-AC 62 XX capsules 10 mg by single administration in healthy volunteers.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UH-AC 62 XX tablet

Group Type: EXPERIMENTAL

UH-AC 62 XX tablet

Intervention Type: DRUG

UH-AC 62 XX capsule

Intervention Type: DRUG

UH-AC 62 XX capsule

Group Type: ACTIVE_COMPARATOR

UH-AC 62 XX tablet

Intervention Type: DRUG

UH-AC 62 XX capsule

Intervention Type: DRUG

Interventions

UH-AC 62 XX tablet

Intervention Type: DRUG

UH-AC 62 XX capsule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 20 and ≤ 35 years
• Weight : Body Mass Index ≥ 18.5 and < 25
• 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 to this study by written informed consent

Exclusion Criteria

• History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy)
• History of hypersensitivity to UH-AC 62 XX (meloxicam) or salicylate (aspirin etc.) or Non-steroidal anti-inflammatory drugs (NSAIDs)
• History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
• A tendency of bleeding
• History of alcohol or drug abuse
• Taking 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 trial
• Donation of constituent of blood of more than 400 mL within 1 month prior to the trial
• Any medication which could 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 were 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

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

107.260

Identifier Type: -

Identifier Source: org_study_id