Bioequivalence Study of UH-AC 62 XX Tablets Compared With the Capsule Formulations in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: UH-AC 62 XX tablet; Drug: UH-AC 62 XX capsule

• Registration Number: NCT02181907
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to investigate the bioequivalence of UH-AC 62 XX tablets 10 mg (TF4) and UH-AC 62 XX capsules 10 mg by single administration in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2003-04
• Status Verified: 2014-07
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-07
• Last Update Submitted: 2014-07-07
• Study First Posted: 2014-07-08
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

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 to this study by written informed consent

Exclusion Criteria

• History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy)
• History of hypersensitivity to UH-AC 62 XX (meloxicam) or salicylate (aspirin etc.) or Non-steroidal anti-inflammatory drugs (NSAIDs)
• History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
• A tendency of bleeding
• History of alcohol or drug abuse
• Taking 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 could 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 were 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
UH-AC 62 XX tablet	UH-AC 62 XX tablet	-
UH-AC 62 XX tablet	UH-AC 62 XX capsule	-
UH-AC 62 XX capsule	UH-AC 62 XX tablet	-
UH-AC 62 XX capsule	UH-AC 62 XX capsule	-

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
Tmax (Time to reach Cmax)	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
MRTpo (Mean residence time of the analyte in the body after single dose po administration)	up to 60 hours after drug administration
t1/2 ( Terminal half-life of the analyte in plasma)	up to 60 hours after drug administration
Number of patients with adverse events	up to 20 days after final drug administration