Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-28 @ 8:50 PM
Study NCT ID:
NCT05749861
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2023-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348(5)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2023-02-20', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCt of CKD-348(5)', 'timeFrame': 'Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours', 'description': 'AUCt: Area under the concentration-time curve from time zero to time'}, {'measure': 'Cmax of CKD-348(5)', 'timeFrame': 'Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours', 'description': 'Cmax: Maximum plasma concentration of the drug'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension and Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'A phase I clinical trial to evaluate the tolerability and the pharmacokinetics of CKD-348(5).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adult volunteers aged ≥ 19 years.\n2. Body weight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2\n3. Those who meet the blood pressure criteria during screening tests:\n\n * Systolic Blood Pressure: 90 to 139 mmHg\n * Diastolic Blood Pressure: 60 to 89 mmHg\n4. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.\n5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and ECG results at screening.\n6. Those who agree to contraception during the participation of clinical trial.\n7. Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.\n\nExclusion Criteria:\n\n1. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.\n2. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products.\n3. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.\n4. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.\n5. Those who exceed an alcohol and cigarette consumption criteria write below within 1 month before the first administration of investigational products.\n\n * Alcohol: Man - 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)\n * Smoking: 20 cigarettes/day\n6. Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism.\n7. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.\n8. Those who are deemed insufficient to participate in this clinical trial by investigators.\n9. Woman who are pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT05749861', 'briefTitle': 'A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348(5)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A Phase I Clinical Trial to Evaluate the Tolerability and the Pharmacokinetics of CKD-348(5) Compared With Co-administration of CKD-828, D097, and D337 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'A86_12BE2301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition\n\nPeriod 2: CKD-348(5) - A single oral dose of 1 tablet under fasting condition\n\nPeriod 3: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition\n\nPeriod 4: CKD-348(5) - A single oral dose of 1 tablet under fasting condition', 'interventionNames': ['Drug: CKD-348(5)', 'Drug: CKD-828, D097, D337']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'Period 1: CKD-348(5) - A single oral dose of 1 tablet under fasting condition\n\nPeriod 2: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition\n\nPeriod 3: CKD-348(5) - A single oral dose of 1 tablet under fasting condition\n\nPeriod 4: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition', 'interventionNames': ['Drug: CKD-348(5)', 'Drug: CKD-828, D097, D337']}], 'interventions': [{'name': 'CKD-348(5)', 'type': 'DRUG', 'description': 'QD, PO', 'armGroupLabels': ['Sequence 1', 'Sequence 2']}, {'name': 'CKD-828, D097, D337', 'type': 'DRUG', 'description': 'QD, PO', 'armGroupLabels': ['Sequence 1', 'Sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'H plus Yangji hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jaewoo Kim, M.D. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H Plus Yangji Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}