Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-02-01 @ 11:02 PM
Study NCT ID:
NCT01973933
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2013-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-Drug Interaction of Pyrimethamine and Metformin IR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D011739', 'term': 'Pyrimethamine'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-10-27', 'studyFirstSubmitDate': '2013-10-27', 'studyFirstSubmitQcDate': '2013-10-27', 'lastUpdatePostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC(area under the plasma concentration-time curve)', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose', 'description': 'AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2'}], 'secondaryOutcomes': [{'measure': 'AUG(total area under the serum concentration-time curve for glucose)', 'timeFrame': 'predose and 15, 30, 45, 60, 90, 120, 150, 180min oral glucose tolerance test', 'description': 'AUG (total area under the serum concentration-time curve for glucose) Gmax(maximum serum glucose concentration)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metformin', 'Pyrimethamine', 'Drug interaction'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of pyrimethamine and metformin IR after oral administration in healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male subject aged 20 to 45 at screening A body weight in the range of 50 kg (inclusive)\n* 100 kg (inclusive) with ideal body weight range of +- 25% subjects who decide to participate voluntarily and write a informed consent form\n\nExclusion Criteria:\n\n* subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor\n* Subject judged not eligible for study participation by investigator.'}, 'identificationModule': {'nctId': 'NCT01973933', 'briefTitle': 'Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-Drug Interaction of Pyrimethamine and Metformin IR', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Open-label, Single Sequence Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Pyrimethamine and Metformin IR After Oral Administration in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'MPI02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin and Pyrimethamine', 'description': 'Metformin 750mg(D1), Metformin 500mg(D2)/Metformin 750mg+Pyrimethamine 50mg(D7), Metformin 500mg+Pyrimethamine 50mg(D8)', 'interventionNames': ['Drug: Metformin and Pyrimethamine']}], 'interventions': [{'name': 'Metformin and Pyrimethamine', 'type': 'DRUG', 'otherNames': ['Diabex', 'Daraprim'], 'armGroupLabels': ['Metformin and Pyrimethamine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jae-Yong Chung, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jae Yong Chung', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}