A Drug Interaction Study of Montelukast and Levocetirizine

Hanmi Pharmaceutical Company Limited30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

LevocetirizineDRUG

Levocetirizine dihydrochloride 5mg. PO. Single dose.

montelukast sodiumDRUG

Montelukast sodium 10mg. PO. Single dose.

Montelukast & levocetirizineDRUG

Montelukast sodium 10mg \& levocetirizine dihydrochloride 5mg PO. Single dose.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung medical center

Seoul, South Korea

Outcomes

Primary Outcomes

AUClast

Time frame: 0-36hrs

Cmax

Time frame: 0-36hrs

Secondary Outcomes

Tmax

Time frame: 0-36hrs

T1/2

Time frame: 0-36hrs

AUCinf

Time frame: 0-36hrs

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.