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A Drug Interaction Study of Montelukast and Levocetirizine (MOLZ)

This study has been completed.
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited Identifier:
First received: October 14, 2011
Last updated: April 4, 2013
Last verified: April 2013
The purpose of this study is to evaluate the drug-drug interaction between montelukast sodium and levocetirizine dihydrochloride in healthy male volunteers.

Condition Intervention Phase
Drug: Levocetirizine
Drug: montelukast sodium
Drug: Montelukast & levocetirizine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label, Randomized, 6-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Montelukast Sodium and Levocetirizine Dihydrochloride in Health Male Volunteers

Resource links provided by NLM:

Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • AUClast [ Time Frame: 0-36hrs ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: 0-36hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tmax [ Time Frame: 0-36hrs ] [ Designated as safety issue: No ]
  • T1/2 [ Time Frame: 0-36hrs ] [ Designated as safety issue: No ]
  • AUCinf [ Time Frame: 0-36hrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Montelukast and levocetirizine Drug: Montelukast & levocetirizine
Montelukast sodium 10mg & levocetirizine dihydrochloride 5mg PO. Single dose.
Active Comparator: Montelukast Drug: montelukast sodium
Montelukast sodium 10mg. PO. Single dose.
Active Comparator: Levocetirizine Drug: Levocetirizine
Levocetirizine dihydrochloride 5mg. PO. Single dose.


Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01491503

Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Principal Investigator: Wooseong Huh, MD Samsung Medical Center
  More Information

Responsible Party: Hanmi Pharmaceutical Company Limited Identifier: NCT01491503     History of Changes
Other Study ID Numbers: HM-MOLZ-101 
Study First Received: October 14, 2011
Last Updated: April 4, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanmi Pharmaceutical Company Limited:

Additional relevant MeSH terms:
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Anti-Allergic Agents processed this record on October 21, 2016