Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-01 @ 6:29 PM
Study NCT ID:
NCT00858195
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2009-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007213', 'term': 'Indomethacin'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-27', 'studyFirstSubmitDate': '2009-03-05', 'studyFirstSubmitQcDate': '2009-03-06', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence according to US FDA guidelines.', 'timeFrame': '8 days'}]}, 'conditionsModule': {'keywords': ['Anti-inflammatory'], 'conditions': ['Inflammation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the bioequivalence of Indomethacin ER Capsules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No clinically significant abnormal findings on physical exam, medical history or clinical laboratory results on screening\n\nExclusion Criteria:\n\n* Positive test results for HIV or hepatitis B or C\n* No allergies to indomethacin or related drugs'}, 'identificationModule': {'nctId': 'NCT00858195', 'briefTitle': 'A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sandoz'}, 'officialTitle': 'A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules Under Fasting Conditions', 'orgStudyIdInfo': {'id': 'R06-0547'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Indomethacin 75mg ER Capsules', 'interventionNames': ['Drug: Indomethacin 75mg Extended-Release Capsules, Sandoz']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Indocin 75mg SR Capsules', 'interventionNames': ['Drug: Indocin 75mg SR Capsules']}], 'interventions': [{'name': 'Indomethacin 75mg Extended-Release Capsules, Sandoz', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'Indocin 75mg SR Capsules', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anthony R Godfrey, Pharm. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PRACS Institute, LTD.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sandoz', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Eric Mittleberg, Ph.D., VP Product Development', 'oldOrganization': 'Sandoz Inc'}}}}