Bioequivalence Study of UHAC62XX Tablets Compared With Capsules in Healthy Volunteers

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: UHAC 62 XX capsule

Drug: UHAC 62 XX tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT02187575

107.259

Details and patient eligibility

About

Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules (reference drug) of meloxicam (UHAC 62 XX) after 7-day administration.

Enrollment

26 patients

Sex

Male

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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 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 etc.) 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 trial
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