Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 10:35 PM
Study NCT ID:
NCT00905333
Status:
COMPLETED
Last Update Posted:
2010-12-07
First Post:
2009-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C081643', 'term': 'candesartan'}, {'id': 'D015736', 'term': 'Felodipine'}, {'id': 'C077793', 'term': 'candesartan cilexetil'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-06', 'studyFirstSubmitDate': '2009-05-19', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®.', 'timeFrame': '76 blood samples per subject'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'candesartan', 'felodipine', 'test formulations', 'Atacand®', 'Splendil®', 'healthy volunteers', 'blood samples', 'after meal intake interaction', 'Kinetic interaction amongst test formulations of Candesartan and Felodipine and the brands Atacand® and Splendil® in healthy volunteers after a fasting period.'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations of candesartan and felodipine in a combination package comparing with the fasting intake of commercial formulations of both Atacand ® and Splendil®'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n* BMI \\> or = 19 and \\< or = 28 (Dietary Guidelines Advisory Committee, 2005)\n\nExclusion Criteria:\n\n* Not healthy\n* Chronic drug intake'}, 'identificationModule': {'nctId': 'NCT00905333', 'briefTitle': 'Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine in a Combination Package Compared to the Separate Intake of the Reference Brands Atacand and Splendil After a Fasting Period.', 'orgStudyIdInfo': {'id': 'D2452L00021'}, 'secondaryIdInfos': [{'id': 'IMPACT 15381'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single-arm', 'description': "3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)", 'interventionNames': ['Drug: Candesartan (test)', 'Drug: Felodipine (test)', 'Drug: Candesartan Cilexetil', 'Drug: Felodipine']}], 'interventions': [{'name': 'Candesartan (test)', 'type': 'DRUG', 'description': '16 mg oral tablet, single dose', 'armGroupLabels': ['Single-arm']}, {'name': 'Felodipine (test)', 'type': 'DRUG', 'description': '5 mg oral extended release tablet, single dose', 'armGroupLabels': ['Single-arm']}, {'name': 'Candesartan Cilexetil', 'type': 'DRUG', 'otherNames': ['Atacand®'], 'description': '16 mg oral tablet, single dose', 'armGroupLabels': ['Single-arm']}, {'name': 'Felodipine', 'type': 'DRUG', 'otherNames': ['Splendil®'], 'description': '5 mg oral extended release tablet, single dose', 'armGroupLabels': ['Single-arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Itatiba', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -23.00583, 'lon': -46.83889}}, {'city': 'Americana', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -22.73917, 'lon': -47.33139}}], 'overallOfficials': [{'name': 'Eduardo Abib Junior, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scentryphar Clinical Research'}, {'name': 'Moises L. P Vanuncci, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Scentryphar Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Scentryphar Clinical Research', 'class': 'OTHER'}, {'name': 'Cori Analyticals', 'class': 'UNKNOWN'}, {'name': 'Clínica São Lucas, Hospital Sírio Libanês de Itatiba S/C', 'class': 'UNKNOWN'}, {'name': 'LabClin Laboratório Clínico', 'class': 'UNKNOWN'}, {'name': 'Laboratório de Patologia Clínica Dr. Franceschi Ltda.', 'class': 'UNKNOWN'}, {'name': 'Faculty of Pharmaceutical Sciences of Ribeirão Preto - Bioequivalence Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'MC MD', 'oldOrganization': 'AstraZeneca'}}}}