Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT00648869
Status:
WITHDRAWN
Last Update Posted:
2009-10-27
First Post:
2008-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'whyStopped': 'Drug was not sent', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2008-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-10-25', 'studyFirstSubmitDate': '2008-03-27', 'studyFirstSubmitQcDate': '2008-03-31', 'lastUpdatePostDateStruct': {'date': '2009-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the difference in the pharmacokinetic profile of metformin following administration of two formulations (gum and tablet).', 'timeFrame': '45 days'}], 'secondaryOutcomes': [{'measure': 'To evaluate the effect on blood glucose levels as well as safety and tolerability of one time administration of the Metformin Gum and Metformin tablet.', 'timeFrame': '45 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pharmaceutical preparations'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Single-dose, randomized, open-label, cross over study. The study will have an open-label, 3 period, 3 treatments, and randomized design.\n\nEach volunteer will receive a Metformin gum 2x250mg, Metformin gum 1x250mg \\& Metformin tablet 500mg'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men ranging in age from 18-40\n* Good general health as determined by medical history, physical examination, ECG, Blood pressure, and clinical laboratory tests (hematology \\& clinical chemistry) obtained within 14 days prior to the start of the study.\n* BMI \\>18\\&\\<30.\n* Willing and able to abide by the dietary requirements of the study.\n* Willing and able to give written informed consent in a manner approved by the Ethics Committee.\n\nExclusion Criteria:\n\n* History of known or suspected clinically significant hypersensitivity to any drug.\n* Any protocol-required laboratory test abnormality that is considered clinically significant.\n* Mentally unstable or incompetent.\n* Any illness during the week before.'}, 'identificationModule': {'nctId': 'NCT00648869', 'briefTitle': 'Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Open-label,Randomized, Crossover Study Comparing Metformin Gum and Immediate Release Tablet in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'generex-HMO-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'metformin tablet, metformin gum', 'type': 'DRUG', 'description': '500 mg, 250 mg'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Diabetes Unit, Hadassah Hebew University Hospital', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Itamar Raz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Hebrew University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Itamar Raz', 'oldOrganization': 'Hadassah Medical Organization, Jerusalem, Israel'}}}}