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A Drug Interaction Study of Montelukast and Levocetirizine (MOLZ)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01491503
First received: October 14, 2011
Last updated: April 4, 2013
Last verified: April 2013
History of Changes
  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
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:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov 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:
montelukast
levocetirizine
interaction

Additional relevant MeSH terms:
Montelukast
Levocetirizine
Cetirizine
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
 Respiratory System Agents
Therapeutic Uses
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents

ClinicalTrials.gov processed this record on May 22, 2013