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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim

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