Bioequivalence Study of UHAC 62 XX 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

NCT02180490

107.252

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) in fasted state.

Enrollment: 60 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 UHAC 62 XX and/or salicylate (aspirin) 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 administration
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

UHAC 62 XX tablet

Experimental group

Treatment:

Drug: UHAC 62 XX tablet

Drug: UHAC 62 XX capsule

UHAC 62 XX capsule

Active Comparator group

Treatment:

Drug: UHAC 62 XX tablet

Drug: UHAC 62 XX capsule