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

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

Summary

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.

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

Details

• Lead Sponsor: Boehringer Ingelheim

Criteria

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