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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: UHAC 62 XX - TF1 tablet; Drug: UHAC 62 XX - capsules; Drug: UHAC 62 XX - TF2 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02180477

107.251

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: Male

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

UHAC 62 XX TF1 tablet

Experimental group

Treatment:

Drug: UHAC 62 XX - TF2 tablet

Drug: UHAC 62 XX - capsules

Drug: UHAC 62 XX - TF1 tablet

UHAC 62 XX TF2 tablet

Experimental group

Treatment:

Drug: UHAC 62 XX - TF2 tablet

Drug: UHAC 62 XX - capsules

Drug: UHAC 62 XX - TF1 tablet

UHAC 62 XX capsule

Active Comparator group

Treatment:

Drug: UHAC 62 XX - TF2 tablet

Drug: UHAC 62 XX - capsules

Drug: UHAC 62 XX - TF1 tablet