A Drug Interaction Study of Montelukast and Levocetirizine

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Montelukast & levocetirizine; Drug: montelukast sodium; Drug: Levocetirizine

• Registration Number: NCT01491503
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

The purpose of this study is to evaluate the drug-drug interaction between montelukast sodium and levocetirizine dihydrochloride in healthy male volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-14
• Study Start: 2011-11
• Study First Submitted QC: 2011-12-13
• Study First Posted: 2011-12-14
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-04
• Last Update Posted: 2013-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Healthy male
• Age between 20 and 55
• Signed informed consent

Exclusion Criteria

• Has a history of hypersensitivity to IP ingredients
• Hypotension or hypertension
• Has a history of acute infection within 14days of screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Montelukast and levocetirizine	Montelukast & levocetirizine	-
Montelukast	montelukast sodium	-
Levocetirizine	Levocetirizine	-

Primary Outcome Measures

Name	Time	Method
AUClast	0-36hrs
Cmax	0-36hrs

Secondary Outcome Measures

Name	Time	Method
Tmax	0-36hrs
T1/2	0-36hrs
AUCinf	0-36hrs

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of