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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: UHAC 62 XX - TF1 tablet; Drug: UHAC 62 XX - TF2 tablet; Drug: UHAC 62 XX - capsules

• Registration Number: NCT02180477
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2001-12
• Status Verified: 2014-07
• Study First Submitted: 2014-07-01
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-02
• Last Update Submitted: 2014-07-04
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
UHAC 62 XX TF1 tablet	UHAC 62 XX - TF1 tablet	-
UHAC 62 XX TF1 tablet	UHAC 62 XX - TF2 tablet	-
UHAC 62 XX TF1 tablet	UHAC 62 XX - capsules	-
UHAC 62 XX TF2 tablet	UHAC 62 XX - TF1 tablet	-
UHAC 62 XX TF2 tablet	UHAC 62 XX - TF2 tablet	-
UHAC 62 XX TF2 tablet	UHAC 62 XX - capsules	-
UHAC 62 XX capsule	UHAC 62 XX - TF1 tablet	-
UHAC 62 XX capsule	UHAC 62 XX - TF2 tablet	-
UHAC 62 XX capsule	UHAC 62 XX - capsules	-

Primary Outcome Measures

Name	Time	Method
AUC 0-72hr (Area under the concentration-time curve in plasma from zero time to 72 hours)	up to 72 hours after administration
Cmax (Maximum observed concentration in plasma)	up to 72 hours after administration

Secondary Outcome Measures

Name	Time	Method
tmax (Time to reach maximum concentration)	up to 72 hours after administration
t1/2 (Terminal half-life in plasma)	up to 72 hours after administration
AUC 0-infinity (Area under the concentration-time curve in plasma from zero time to infinity)	up to 72 hours after administration
Number of patients with adverse events	up to 14 days after last administration
MRT 0-t (Mean residence time in the body from zero time to the time of the last quantifiable drug concentration)	up to 72 hours after administration