A Drug Interaction Study of Montelukast and Levocetirizine (MOLZ)

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. Identifier: NCT01491503
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : April 5, 2013
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Levocetirizine Drug: montelukast sodium Drug: Montelukast & levocetirizine Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : November 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. AUClast [ Time Frame: 0-36hrs ]
  2. Cmax [ Time Frame: 0-36hrs ]

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

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

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

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 identifier (NCT number): 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

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

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