Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT01423305
Status:
COMPLETED
Last Update Posted:
2011-10-21
First Post:
2011-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Pharmacokinetic Study (BF-BLOCK)
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': 'D019819', 'term': 'Budesonide'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'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': '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': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-20', 'studyFirstSubmitDate': '2011-08-23', 'studyFirstSubmitQcDate': '2011-08-24', 'lastUpdatePostDateStruct': {'date': '2011-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The evaluation of primary pharmacokinetic variable AUCt', 'timeFrame': '4 weeks', 'description': 'The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover design.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic variables', 'timeFrame': '4 weeks', 'description': 'Cmax'}, {'measure': 'Pharmacokinetic variable', 'timeFrame': '4 weeks', 'description': 'tmax'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to assess if charcoal prevents the absorption of budesonide and formoterol via GI track. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy males and females aged 18-60 years.\n2. Normal weight at least 50 kg.\n\nExclusion Criteria:\n\n1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.\n2. Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.\n3. Any condition requiring concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.\n4. Known hypersensitivity to the active substance(s) or the excipients of the drug.\n5. Pregnant or lactating females.'}, 'identificationModule': {'nctId': 'NCT01423305', 'acronym': 'BF-BLOCK', 'briefTitle': 'Phase I Pharmacokinetic Study (BF-BLOCK)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orion Corporation, Orion Pharma'}, 'officialTitle': 'Effect of Charcoal on Gastrointestinal Absorption of Budesonide and Formoterol', 'orgStudyIdInfo': {'id': '3103008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'Budesonide/formoterol capsule (Orion Pharma) for oral administration.', 'interventionNames': ['Drug: Budesonide/formoterol capsule.']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': 'Budesonide/formoterol capsule (Orion Pharma) for oral administration.', 'interventionNames': ['Drug: Budesonide/formoterol capsule for oral adm.']}], 'interventions': [{'name': 'Budesonide/formoterol capsule.', 'type': 'DRUG', 'description': 'Oral administration with concomitant charcoal.', 'armGroupLabels': ['Treatment A']}, {'name': 'Budesonide/formoterol capsule for oral adm.', 'type': 'DRUG', 'description': 'Oral administration without concomitant charcoal.', 'armGroupLabels': ['Treatment B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Clinical Reseach Services Turku (CRST)', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Mika Scheinin, M.D.Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Services Turku Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orion Corporation, Orion Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}