Overview

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