Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-03-08 @ 11:44 PM
Study NCT ID:
NCT00562250
Status:
COMPLETED
Last Update Posted:
2016-10-17
First Post:
2007-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'C057619', 'term': 'glimepiride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-14', 'studyFirstSubmitDate': '2007-11-21', 'studyFirstSubmitQcDate': '2007-11-21', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together', 'timeFrame': 'plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose'}], 'secondaryOutcomes': [{'measure': 'Measures of the plasma concentration of the active metabolite of glimepiride when administered alone or coadministered with glimepiride', 'timeFrame': 'for 72 hours after each administered dose'}, {'measure': 'Recorded adverse events', 'timeFrame': 'for 72 hours after each administered dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3634&filename=MB102-016%20_CSR%20_synosis.pdf', 'label': 'MB102-016 \\_CSR \\_synosis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects with BMI of 18-32 kg/m2\n\nExclusion Criteria:\n\n* Abnormal physical or lab findings\n* Allergies to any sulfonylurea or related compounds'}, 'identificationModule': {'nctId': 'NCT00562250', 'briefTitle': 'Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects', 'orgStudyIdInfo': {'id': 'MB102-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'interventionNames': ['Drug: Glimepiride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 3', 'interventionNames': ['Drug: Dapagliflozin + Glimepiride']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'description': 'Tablets, Oral, 20 mg, once daily, single dose', 'armGroupLabels': ['Arm 1']}, {'name': 'Glimepiride', 'type': 'DRUG', 'description': 'Tablets, Oral, 4 mg, once daily, single dose', 'armGroupLabels': ['Arm 2']}, {'name': 'Dapagliflozin + Glimepiride', 'type': 'DRUG', 'description': 'Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose', 'armGroupLabels': ['Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1602', 'city': 'Vicente López', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Local Institution', 'geoPoint': {'lat': -34.52947, 'lon': -58.4737}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}