Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-27 @ 8:40 PM
Study NCT ID:
NCT00280358
Status:
COMPLETED
Last Update Posted:
2008-03-07
First Post:
2006-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study in Healthy Volunteers to Evaluate Serum and Urine Levels of the Investigational Product Versus Comparator.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-05', 'studyFirstSubmitDate': '2006-01-19', 'studyFirstSubmitQcDate': '2006-01-20', 'lastUpdatePostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of study medication in blood and urine.'}], 'secondaryOutcomes': [{'measure': 'Safety/tolerability'}]}, 'conditionsModule': {'keywords': ['Fluticasone', 'Formoterol', 'PK Study', 'Pharmacokinetics'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to obtain initial pharmacokinetic data in healthy patients after dosing a combination of the study medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-smokers, BMI 18-29, no current medications\n\nExclusion Criteria:\n\n* Significant conditions or disease'}, 'identificationModule': {'nctId': 'NCT00280358', 'briefTitle': 'A Study in Healthy Volunteers to Evaluate Serum and Urine Levels of the Investigational Product Versus Comparator.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dey'}, 'orgStudyIdInfo': {'id': '191-072'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fluticasone Propionate', 'type': 'DRUG'}, {'name': 'Formoterol Fumarate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dey', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director Clinical Affairs', 'oldOrganization': 'Dey, LP'}}}}