Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-28 @ 6:50 AM
Study NCT ID:
NCT03970434
Status:
COMPLETED
Last Update Posted:
2019-06-13
First Post:
2019-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Concentration of Metformin According to Sampling Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': '2019-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-12', 'studyFirstSubmitDate': '2019-05-17', 'studyFirstSubmitQcDate': '2019-05-30', 'lastUpdatePostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of Metformin', 'timeFrame': '10 hours', 'description': 'Compare the concentration of Metformin measured from Venous blood collection and Peripheral blood collection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study assess the drug concentration of metformin in healthy adult volunteers according to the sampling method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male subjects who, at the time of screening, are the age of older than 19 years\n* Subjects who have BMI more than 17.5kg/m2 and less than 30.5kg/m2 and body weight more than 55kg\n* There is no congenital disease or within 3 years of chronic diseases\n* Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, ECG or clinical laboratory tests\n* Subjects who signed and dated the informed consent form(approved by IRB) after understanding fully to hear a detailed explanation in the clinical trial\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease\n* A subject with any history of gastrointestinal disease (e.g., Crohn's disease, acute or chronic pancreatitis, and others) and surgery (except for simple appendectomy or repair of a hernia), which can influence the absorption of investigational products\n* A subject who has the following clinical laboratory test results Liver Function Test (AST, ALT) \\> two times the upper limit of the normal range\n* History of regular alcohol consumption exceeding 210g/week(12g = 125 mL of wine, 10g = 250 mL of beer, 10g = 50 mL of hard liquor) within 6 months of Screening\n* A subject who has participated in any other clinical trials and had medication within 3 months prior to the first administration of investigational product.\n* A subject with a history of drug abuse or a positive urine drug screening for drug abuse within 1 year\n* A subject who has taken the drugs that induce and suppress drug- metabolizing enzymes within 30 days prior to investigational product administration\n* A smoker who consumes more than 20 cigarettes/day within 6 months\n* A subject who has taken any ethical-the-counter drug or has taken any over- the-counter drug within 10 days before the investigational product administration\n* A subject who has donated whole blood within 2 months or blood components within 1 month prior to the investigational product administration\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation"}, 'identificationModule': {'nctId': 'NCT03970434', 'briefTitle': 'Drug Concentration of Metformin According to Sampling Method', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'officialTitle': 'Clinical Trial to Evaluate Drug Concentration of Metformin According to Sampling Method in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'CUH_2019_MSM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin', 'interventionNames': ['Other: Venous blood collection', 'Other: Peripheral blood collection']}], 'interventions': [{'name': 'Venous blood collection', 'type': 'OTHER', 'description': 'Venous blood collection', 'armGroupLabels': ['Metformin']}, {'name': 'Peripheral blood collection', 'type': 'OTHER', 'description': 'Peripheral blood collection', 'armGroupLabels': ['Metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54907', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Center for Clinical Pharmacology', 'investigatorFullName': 'Min-Gul Kim, MD, PhD', 'investigatorAffiliation': 'Chonbuk National University Hospital'}}}}