Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-02 @ 9:39 AM
Study NCT ID:
NCT03073057
Status:
COMPLETED
Last Update Posted:
2017-03-08
First Post:
2016-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study to Compare Absorption of Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069502', 'term': 'Budesonide, Formoterol Fumarate Drug Combination'}, {'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D002606', 'term': 'Charcoal'}], 'ancestors': [{'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002244', 'term': 'Carbon'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-02', 'studyFirstSubmitDate': '2016-02-15', 'studyFirstSubmitQcDate': '2017-03-02', 'lastUpdatePostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of plasma budesonide and formoterol', 'timeFrame': 'within 24 hours'}, {'measure': 'AUCt of plasma budesonide and formoterol', 'timeFrame': 'within 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare Budesonide/formoterol Easyhaler test products with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent obtained\n* Body mass index \\> 19 and \\< 30kg/m2, weight at least 50 kg\n* Good general health ascertained by detailed medical history, and laboratory and physical examinations\n\nExclusion Criteria:\n\n* Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease\n* Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during a study.\n* Known hypersensitivity to the active substance(s) or the excipient of the drug\n* Pregnant and lactating females'}, 'identificationModule': {'nctId': 'NCT03073057', 'briefTitle': 'Pharmacokinetic Study to Compare Absorption of Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orion Corporation, Orion Pharma'}, 'officialTitle': 'Pharmacokinetic Pilot Study Comparing Three Formulations of Budesonide/Formoterol Easyhaler 160/4.5 Microg/Inhalation and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects', 'orgStudyIdInfo': {'id': '3103014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Charcoal and Budesonide/formoterol Easyhaler A', 'description': '160/4.5microg/inhalation Charcoal', 'interventionNames': ['Drug: Budesonide/formoterol', 'Other: Charcoal']}, {'type': 'EXPERIMENTAL', 'label': 'Charcoal and Budesonide/formoterol Easyhaler B', 'description': '160/4.5microg/inhalation Charcoal', 'interventionNames': ['Drug: Budesonide/formoterol', 'Other: Charcoal']}, {'type': 'EXPERIMENTAL', 'label': 'Charcoal and Budesonide/formoterol Easyhaler C', 'description': '160/4.5microg/inhalation Charcoal', 'interventionNames': ['Drug: Budesonide/formoterol', 'Other: Charcoal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Charcoal and Symbicort Turbuhaler', 'description': '160/4.5microg/inhalation Charcoal', 'interventionNames': ['Other: Charcoal', 'Drug: Symbicort Turbuhaler']}], 'interventions': [{'name': 'Budesonide/formoterol', 'type': 'DRUG', 'otherNames': ['Budesonide/formoterol 160/4.5microg'], 'description': '2 inhalations as a single dose', 'armGroupLabels': ['Charcoal and Budesonide/formoterol Easyhaler A', 'Charcoal and Budesonide/formoterol Easyhaler B', 'Charcoal and Budesonide/formoterol Easyhaler C']}, {'name': 'Charcoal', 'type': 'OTHER', 'armGroupLabels': ['Charcoal and Budesonide/formoterol Easyhaler A', 'Charcoal and Budesonide/formoterol Easyhaler B', 'Charcoal and Budesonide/formoterol Easyhaler C', 'Charcoal and Symbicort Turbuhaler']}, {'name': 'Symbicort Turbuhaler', 'type': 'DRUG', 'otherNames': ['Symbicort Turbuhaler 160/4.5 microg'], 'description': '2 inhalations as a single dose', 'armGroupLabels': ['Charcoal and Symbicort Turbuhaler']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02100', 'city': 'Espoo', 'country': 'Finland', 'facility': 'Orion Pharma, Clinical Pharmacology Unit', 'geoPoint': {'lat': 60.2052, 'lon': 24.6522}}], 'overallOfficials': [{'name': 'Iissa Kivisto', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Orion Corporation, Orion Pharma'}, {'name': 'Leena Mattila, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orion Pharma, Clinical Pharmacology Unit, Espoo, Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orion Corporation, Orion Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}