Bioequivalence Study of UHAC62XX Tablets Compared With Capsules in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: UHAC 62 XX capsule; Drug: UHAC 62 XX tablet

• Registration Number: NCT02187575
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules (reference drug) of meloxicam (UHAC 62 XX) after 7-day administration.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Primary Completion: 2002-09
• Status Verified: 2014-07
• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-10
• Study First Posted: 2014-07-11
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

Inclusion Criteria

• Age >= 20 and <= 35 years
• Weight: Body Mass Index >= 18.5 and < 25
• 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 etc.) 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 trial
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
UHAC 62 XX capsule	UHAC 62 XX capsule	-
UHAC 62 XX tablet	UHAC 62 XX tablet	-

Primary Outcome Measures

Name	Time	Method
AUC 0-τ (Area under the concentration time curve in plasma from zero time to 24 hours after 7-day administration)	up to day 8
Cmax (maximum observed concentration of the analyte in plasma)	up to day 8

Secondary Outcome Measures

Name	Time	Method
Tmax (Time to reach Cmax)	up to day 8
Number of patients with adverse events	up to 20 days after final administration
T1/2 (Terminal half-life in plasma)	up to day 8
MRT 0-τ (Mean residence time in the body after 7-day administration)	up to day 8
Cτ (Concentration of the analyte in plasma 24 hours after 7-day administration)	up to day 8