Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-31 @ 3:00 PM
Study NCT ID:
NCT04438733
Status:
UNKNOWN
Last Update Posted:
2020-06-30
First Post:
2020-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fasted Condition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-27', 'studyFirstSubmitDate': '2020-06-17', 'studyFirstSubmitQcDate': '2020-06-18', 'lastUpdatePostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the ratios of geometrical mean', 'timeFrame': '31 days', 'description': 'The two preparations were considered bioequivalent if the 90% CIs of the ratios of the primary pharmacokinetics parameters were within the predefined acceptance range of 80%-125%.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'An open-label, randomized, two-period, two-group, crossover study was conducted in 26 healthy Chinese volunteers under fasted conditions to assess the bioequivalence between two formulations of Anastrozole.', 'detailedDescription': 'Anastrozole is currently used as first-line treatment in locally advanced or metastatic breast cancer. A generic anastrozole tablet was developed to offer an alternative to the marketed tablet formulation.The aim of the current study was to evaluate the bioequivalence between the test and reference formulations of anastrozole in a single-dose, 2-period, 2-sequence crossover study with a 21-day washout interval. A total of 26 healthy Chinese female volunteers were enrolled and completed the study, after oral administration of a single dose of 1.0-mg test and reference formulations of anastrozole. Blood samples (3 mL) for pharmacokinetic analysis were collected predose and 20min, 40min, 1, 1h20min, 1h40min, 2, 2h20min, 2h40min, 3, 3.5, 4, 7, 12, 24, 48, and 72 hours postdose and were determined by a fully validated high-pressure liquid chromatography-tandem mass spectrometry method. The evaluated pharmacokinetic parameters, including Cmax, AUC0-t, AUC0-∞, were assessed for bioequivalence based on current guidelines.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Postmenopausal volunteers aged between 18 and 65 years old.\n* The body mass index is in the range of 19.0-28.0 kg/m2 (including the critical value). The weight is not less than 45 kg.\n* The subjects have no family planning within 6 months and could select contraceptive method.\n* Subjects who had not any medical history of cardiovascular, digestive, respiratory, nervous, haemal diseases or hepatic/renal impairment.\n\nExclusion Criteria:\n\n* Meet the diagnostic criteria for osteoporosis.\n* Subjects with vaginal bleeding.\n* blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening.\n* any use of other prescription drugs (including contraceptive) 28 days prior to medication for this study.\n* any history of alcohol abuse in the recent 2 years or moderate drinkers (drink more 2 units per day or 14 units per week);\n* smoking more than 5 cigarettes per day during the 3 months prior to screening;'}, 'identificationModule': {'nctId': 'NCT04438733', 'briefTitle': 'Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fasted Condition', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Qingdao University'}, 'officialTitle': 'Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fasted Condition: A Open-label, Randomized,Single-dose,Two-period, Two-group, Crossover Study', 'orgStudyIdInfo': {'id': 'TG1914ANA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'test-anastrozole tablet', 'description': '1 mg anastrozole was produced and provided by Salutas Pharma GmbH', 'interventionNames': ['Drug: test-anastrozole tablet (Salutas Pharma GmbH)']}, {'type': 'EXPERIMENTAL', 'label': 'reference-anastrozole tablet', 'description': '1 mg anastrozole was produced by AstraZeneca Pharmaceuticals LP.', 'interventionNames': ['Drug: reference-anastrozole tablet (Arimidex)']}], 'interventions': [{'name': 'test-anastrozole tablet (Salutas Pharma GmbH)', 'type': 'DRUG', 'description': 'Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex', 'armGroupLabels': ['test-anastrozole tablet']}, {'name': 'reference-anastrozole tablet (Arimidex)', 'type': 'DRUG', 'otherNames': ['Arimidex'], 'description': 'Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex', 'armGroupLabels': ['reference-anastrozole tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '266003', 'city': 'Qingdao', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yu Cao, doctor', 'role': 'CONTACT', 'email': 'caoyu1767@126.com', 'phone': '86 18661809090'}, {'name': 'ye Tao, master', 'role': 'CONTACT', 'email': 'taoye165298765@163.com', 'phone': '86 17853287551'}], 'facility': 'Phase I Clinical Research Center', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}], 'centralContacts': [{'name': 'yu Cao, doctor', 'role': 'CONTACT', 'email': 'caoyu1767@126.com', 'phone': '86 18661809090'}, {'name': 'ye Tao, master', 'role': 'CONTACT', 'email': 'taoye165298765@163.com', 'phone': '86 17853287551'}], 'overallOfficials': [{'name': 'yu Cao, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'the study director of phase I clinical research center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}