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

Phase 1

Completed

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

• Registration Number: NCT02180490
• 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) in fasted state.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2002-07
• 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: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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