Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT01155102
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2010-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalency Study of Anastrozole 1 mg Under Fasted Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077384', 'term': 'Anastrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-19', 'studyFirstSubmitDate': '2010-06-28', 'studyFirstSubmitQcDate': '2010-06-30', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bioequivalence determined by statistical comparison Cmax', 'timeFrame': '31 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to prove the bioequivalence of Anastrozole Tablet under fasted conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening\n\nExclusion Criteria:\n\n* Positive test for HIV, Hepatitis B, or Hepatitis C.\n* Treatment with known enzyme altering drugs.\n* History of allergic or adverse response to anastrozole or any comparable or similar product.'}, 'identificationModule': {'nctId': 'NCT01155102', 'briefTitle': 'Bioequivalency Study of Anastrozole 1 mg Under Fasted Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'West-Ward Pharmaceutical'}, 'officialTitle': 'A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Anastrozole 1 mg Tablets Under Fasting Conditions', 'orgStudyIdInfo': {'id': 'ANAS-T1-PVFS-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Anastrozole', 'type': 'DRUG', 'otherNames': ['ARIMIDEX'], 'description': '1 mg tablet'}]}, 'contactsLocationsModule': {'locations': [{'zip': '65802', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Bio-Kinetic Clinical Applications', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}], 'overallOfficials': [{'name': 'Dennis Morrison, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bio-Kinetic Clinical Applications'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roxane Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Elizabeth Ernst, Director, Drug Regulatory and Medical Affairs', 'oldOrganization': 'Roxane Laboratories, Inc.'}}}}