NCT01491503

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2011

Completed
18 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

2 months

First QC Date

October 14, 2011

Last Update Submit

April 4, 2013

Conditions

Healthy

Keywords

montelukastlevocetirizineinteraction

Outcome Measures

Primary Outcomes (2)

  • AUClast

    0-36hrs

  • Cmax

    0-36hrs

Secondary Outcomes (3)

  • Tmax

    0-36hrs

  • T1/2

    0-36hrs

  • AUCinf

    0-36hrs

Study Arms (3)

Montelukast and levocetirizine

EXPERIMENTAL
Drug: Montelukast & levocetirizine

Montelukast

ACTIVE COMPARATOR
Drug: montelukast sodium

Levocetirizine

ACTIVE COMPARATOR
Drug: Levocetirizine

Interventions

LevocetirizineDRUG

Levocetirizine dihydrochloride 5mg. PO. Single dose.

Levocetirizine
montelukast sodiumDRUG

Montelukast sodium 10mg. PO. Single dose.

Montelukast
Montelukast & levocetirizineDRUG

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

Montelukast and levocetirizine

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung medical center

Seoul, South Korea

Location

MeSH Terms

Interventions

levocetirizinemontelukast

Study Officials

  • Wooseong Huh, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2011

First Posted

December 14, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations

KR(1)