Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2025-12-27 @ 10:39 PM
Study NCT ID:
NCT03849495
Status:
UNKNOWN
Last Update Posted:
2019-03-12
First Post:
2019-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-370 and D745 in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-03-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-10', 'studyFirstSubmitDate': '2019-02-20', 'studyFirstSubmitQcDate': '2019-02-20', 'lastUpdatePostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUClast of Empagliflozin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Area under the plasma concentration-time curve to last concentration of Empagliflozin'}, {'measure': 'Cmax of Empagliflozin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Maximum plasma concentration of Empagliflozin'}], 'secondaryOutcomes': [{'measure': 'AUCinf of Empagliflozin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Area under the plasma concentration-time curve from zero to infinity concentration of Empagliflozin'}, {'measure': 'Tmax of Empagliflozin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Time to maximum plasma concentration of Empagliflozin'}, {'measure': 'T1/2 of Empagliflozin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Half-life of Empagliflozin'}, {'measure': 'CL/F of Empagliflozin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Apparent clearance of Empagliflozin'}, {'measure': 'Vd/F of Empagliflozin', 'timeFrame': '0 hour ~ 48 hour after drug administration', 'description': 'Apparent volume of distribution of Empagliflozin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'A randomized, open-label, single dose, two-way crossover study to compare the pharmacokinetics and safety/tolerability of CKD-370 with D745 in healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adults aged 19 to 55 years\n2. Females who are not pregnant or breastfeeding or who have 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, digestive, urinary, 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) \\> 1.5 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. Current smokers or those who cannot quit smoking during the period from 90 days before the first IP dosing to the last discharge.\n4. Subject who drink excessive caffeine or alcohol continuously and who cannot discontinue caffeine or alcohol intake during the period from 3 days before the first IP dosing to the last discharge.\n5. Participated in a clinical trial within 90 days prior to first IP dosing\n6. Not eligible to participate for the study at the discretion of Investigator\n7. Other exclusive inclusion criteria, as defined in the protocol'}, 'identificationModule': {'nctId': 'NCT03849495', 'briefTitle': 'Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-370 and D745 in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A Randomized, Open-label, Single Dose, Two-way Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-370 With D745 in Healthy Volunteers', 'orgStudyIdInfo': {'id': '191BE18033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': '* Period 1: D745\n* Period 2: CKD-370', 'interventionNames': ['Drug: CKD-370', 'Drug: D745']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': '* Period 1: CKD-370\n* Period 2: D745', 'interventionNames': ['Drug: CKD-370', 'Drug: D745']}], 'interventions': [{'name': 'CKD-370', 'type': 'DRUG', 'description': 'Test drug', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'D745', 'type': 'DRUG', 'description': 'Reference drug', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyung Sang Yu, Ph.D. M.D.', 'role': 'CONTACT', 'phone': '+82-2-2072-1920'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Kyung Sang Yu, Ph.D. M.D.', 'role': 'CONTACT', 'phone': '+82-2-2072-1920'}, {'name': 'Deok Yong Yoon', 'role': 'CONTACT', 'email': 'dyyoon18@snu.ac.kr', 'phone': '+82-2-2072-1930'}], 'overallOfficials': [{'name': 'Kyung Sang Yu, Ph.D. M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}