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A Drug Interaction Study of Montelukast and Levocetirizine (MOLZ)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01491503
First Posted: December 14, 2011
Last Update Posted: April 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
  Purpose
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
Healthy Drug: Levocetirizine Drug: montelukast sodium Drug: Montelukast & levocetirizine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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 ]
  • Cmax [ Time Frame: 0-36hrs ]

Secondary Outcome Measures:
  • Tmax [ Time Frame: 0-36hrs ]
  • T1/2 [ Time Frame: 0-36hrs ]
  • AUCinf [ Time Frame: 0-36hrs ]

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.

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491503


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

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01491503     History of Changes
Other Study ID Numbers: HM-MOLZ-101
First Submitted: October 14, 2011
First Posted: December 14, 2011
Last Update Posted: April 5, 2013
Last Verified: April 2013

Keywords provided by Hanmi Pharmaceutical Company Limited:
montelukast
levocetirizine
interaction

Additional relevant MeSH terms:
Montelukast
Levocetirizine
Cetirizine
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