Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2026-02-01 @ 5:41 AM
Study NCT ID:
NCT03849261
Status:
UNKNOWN
Last Update Posted:
2019-02-21
First Post:
2019-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-20', 'studyFirstSubmitDate': '2019-02-20', 'studyFirstSubmitQcDate': '2019-02-20', 'lastUpdatePostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of Dapagliflozin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Maximum plasma concentration of Dapagliflozin'}, {'measure': 'Cmax of Metformin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Maximum plasma concentration of Metformin'}, {'measure': 'AUClast of Dapagliflozin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Area under the plasma concentration-time curve to last concentration of Dapagliflozin'}, {'measure': 'AUClast of Metformin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Area under the plasma concentration-time curve to last concentration of Metformin'}], 'secondaryOutcomes': [{'measure': 'AUCinf of Dapagliflozin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Area under the plasma concentration-time curve from zero to infinity concentration of Dapagliflozin'}, {'measure': 'AUCinf of Metformin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Area under the plasma concentration-time curve from zero to infinity concentration of Metformin'}, {'measure': 'Tmax of Dapagliflozin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Time to maximum plasma concentration of Dapagliflozin'}, {'measure': 'Tmax of Metformin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Time to maximum plasma concentration of Metformin'}, {'measure': 'T1/2 of Dapagliflozin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Half-life of Dapagliflozin'}, {'measure': 'T1/2 of Metformin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Half-life of Metformin'}, {'measure': 'Vd/F of Dapagliflozin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Apparent volume of distribution of Dapagliflozin'}, {'measure': 'Vd/F of Metformin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Apparent volume of distribution of Metformin'}, {'measure': 'CL/F of Dapagliflozin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Apparent clearance of Dapagliflozin'}, {'measure': 'CL/F of Metformin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Apparent clearance of Metformin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of the clinical trail is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D635 in healthy adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adults aged 19 to 55 years\n2. Females must be menopause or surgical infertility\n3. Signed informed consent form\n4. Other inclusion criteria, as defined in the protocol\n\nExclusion Criteria:\n\n1. History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder\n2. Clinical laboratory test values are outside the accepted normal range at Screening\n\n * aspartate aminotransferase(AST), alanine aminotransferase(ALT) \\> 1.25 times the upper limit of the normal range\n * Total Bilirubin \\> 1.5 times the upper limit of the normal range\n * creatine phosphokinase(CPK) \\> 1.5 times the upper limit of the normal range\n * estimated Glomerular Filtration Rate(eGFR, MDRD\\* formula) \\< 60 mL/min/1.73m2 (\\*MDRD: Modification of Diet in Renal Disease)\n * Positive reaction on following tests: Hepatitis B, Hepatitis C, human immunodeficiency virus(HIV) and syphilis\n * systolic blood pressure(SBP) ≥ 150 mmHg or \\< 90 mmHg, diastolic blood pressure(DBP) \\> 100 mmHg or \\< 50 mmHg\n3. Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization\n4. Participated in a clinical trial within 90 days prior to 1st IP dosing\n5. Not eligible to participate for the study at the discretion of Investigator\n6. Other exclusive inclusion criteria, as defined in the protocol'}, 'identificationModule': {'nctId': 'NCT03849261', 'briefTitle': 'Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 in Healthy Adults', 'orgStudyIdInfo': {'id': '184BE18026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': '* Period 1: D635\n* Period 2: CKD-387', 'interventionNames': ['Drug: CKD-387', 'Drug: D635']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': '* Period 1: CKD-387\n* Period 2: D635', 'interventionNames': ['Drug: CKD-387', 'Drug: D635']}], 'interventions': [{'name': 'CKD-387', 'type': 'DRUG', 'description': 'Test drug', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'D635', 'type': 'DRUG', 'description': 'Reference drug', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Min Soo Park, Ph.D. M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}