Bioequivalence Study of UHAC 62 XX Tablets Compared With Capsules in Healthy Volunteers

Bioequivalence Study of UHAC 62 XX 10 mg Tablets Compared With 10 mg Capsules Following Single Peroral Administration in Healthy Volunteers (An Open-label, Randomised, Two-way Crossover Study)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: UHAC 62 XX tablet; Drug: UHAC 62 XX capsule

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: UHAC 62 XX capsule	Drug: UHAC 62 XX tablet; Drug: UHAC 62 XX capsule
Experimental: UHAC 62 XX tablet	Drug: UHAC 62 XX tablet; Drug: UHAC 62 XX capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax (Maximum observed concentration of the analyte in plasma)	up to 60 hours after drug administration
AUC 0-60hr (Area under the concentration time curve of the analyte in plasma from zero time to 60 hours)	up to 60 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Tmax (Time to reach Cmax)	up to 60 hours after drug administration
t1/2 ( Terminal half-life of the analyte in plasma)	up to 60 hours after drug administration
AUC 0-infinity (Area under the concentration time curve of the analyte in plasma from zero time to infinity)	up to 60 hours after drug administration
MRT 0-infinity (Mean residence time of the analyte molecules in the body from zero time to infinity)	up to 60 hours after drug administration
Number of patients with adverse events	up to 20 days after final drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Primary Completion (Actual): July 1, 2002

Study Registration Dates

• First Submitted: July 1, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimate): July 2, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 4, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 107.252