A Drug Interaction Study of Montelukast and Levocetirizine

Open Label, Randomized, 6-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Montelukast Sodium and Levocetirizine Dihydrochloride in Health Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01491503

Acronym

MOLZ

Enrollment

Registered

2011-12-14

Start date

2011-11-30

Completion date

2012-01-31

Last updated

2013-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

montelukast, levocetirizine, interaction

Brief summary

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

Interventions

DRUGLevocetirizine

Levocetirizine dihydrochloride 5mg. PO. Single dose.

DRUGmontelukast sodium

Montelukast sodium 10mg. PO. Single dose.

DRUGMontelukast & levocetirizine

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
AUClast	0-36hrs
Cmax	0-36hrs

Secondary

Measure	Time frame
Tmax	0-36hrs
T1/2	0-36hrs
AUCinf	0-36hrs

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026