Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-28 @ 11:20 AM
Study NCT ID:
NCT01491503
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
2011-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug Interaction Study of Montelukast and Levocetirizine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C472067', 'term': 'levocetirizine'}, {'id': 'C093875', 'term': 'montelukast'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-04', 'studyFirstSubmitDate': '2011-10-14', 'studyFirstSubmitQcDate': '2011-12-13', 'lastUpdatePostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUClast', 'timeFrame': '0-36hrs'}, {'measure': 'Cmax', 'timeFrame': '0-36hrs'}], 'secondaryOutcomes': [{'measure': 'Tmax', 'timeFrame': '0-36hrs'}, {'measure': 'T1/2', 'timeFrame': '0-36hrs'}, {'measure': 'AUCinf', 'timeFrame': '0-36hrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['montelukast', 'levocetirizine', 'interaction'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the drug-drug interaction between montelukast sodium and levocetirizine dihydrochloride in healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male\n* Age between 20 and 55\n* Signed informed consent\n\nExclusion Criteria:\n\n* Has a history of hypersensitivity to IP ingredients\n* Hypotension or hypertension\n* Has a history of acute infection within 14days of screening'}, 'identificationModule': {'nctId': 'NCT01491503', 'acronym': 'MOLZ', 'briefTitle': 'A Drug Interaction Study of Montelukast and Levocetirizine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'Open Label, Randomized, 6-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Montelukast Sodium and Levocetirizine Dihydrochloride in Health Male Volunteers', 'orgStudyIdInfo': {'id': 'HM-MOLZ-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Montelukast and levocetirizine', 'interventionNames': ['Drug: Montelukast & levocetirizine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Montelukast', 'interventionNames': ['Drug: montelukast sodium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levocetirizine', 'interventionNames': ['Drug: Levocetirizine']}], 'interventions': [{'name': 'Levocetirizine', 'type': 'DRUG', 'description': 'Levocetirizine dihydrochloride 5mg. PO. Single dose.', 'armGroupLabels': ['Levocetirizine']}, {'name': 'montelukast sodium', 'type': 'DRUG', 'description': 'Montelukast sodium 10mg. PO. Single dose.', 'armGroupLabels': ['Montelukast']}, {'name': 'Montelukast & levocetirizine', 'type': 'DRUG', 'description': 'Montelukast sodium 10mg \\& levocetirizine dihydrochloride 5mg PO. Single dose.', 'armGroupLabels': ['Montelukast and levocetirizine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Wooseong Huh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}