Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-01 @ 4:14 PM
Study NCT ID:
NCT00875966
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2009-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Bioavailability Study of Azithromycin 200mg/5mL Suspension Following a 600mg Dose Under Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D013535', 'term': 'Suspensions'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-27', 'studyFirstSubmitDate': '2009-04-03', 'studyFirstSubmitQcDate': '2009-04-03', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence based on AUC and Cmax', 'timeFrame': '37 days'}]}, 'conditionsModule': {'conditions': ['Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No clinically significant findings on physical exam, medial history or laboratory tests on screening\n\nExclusion Criteria:\n\n* Positive test for HIV or hepatitis B and C\n* Treatment for Drug or alcohol abuse\n* Any other important criteria in the protocol'}, 'identificationModule': {'nctId': 'NCT00875966', 'briefTitle': 'Comparative Bioavailability Study of Azithromycin 200mg/5mL Suspension Following a 600mg Dose Under Fed Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sandoz'}, 'officialTitle': 'Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Eon and Pfizer Inc. (ZITHROMAX) 200mg/5mL Azithromycin Suspension Following a 600mg Dose in Healthy Adult Volunteers Under Fed Conditions', 'orgStudyIdInfo': {'id': 'AA17045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Azithromycin for oral suspension 200mg/5mL', 'interventionNames': ['Drug: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Zithromax (azithromycin for oral suspension) 200mg/5mL', 'interventionNames': ['Drug: Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer']}], 'interventions': [{'name': 'Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer', 'type': 'DRUG', 'description': 'Subjects randomized to Zithromax received a single oral dose of Zithromax 600mg (15mL), administered with 240mL of water under fed conditions', 'armGroupLabels': ['2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sandoz', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Eric Mittleberg, Ph.D., VP Product Development', 'oldOrganization': 'Sandoz Inc.'}}}}