Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
Study NCT ID:
NCT04587206
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2020-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Evaluate the Pharmacokinetics and Tolerability of CKD-348
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': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2020-10-07', 'studyFirstSubmitQcDate': '2020-10-07', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCt of CKD-348', 'timeFrame': '[Time Frame: 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', 'timeFrame': '[Time Frame: 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'}], 'secondaryOutcomes': [{'measure': 'AUCinf of CKD-348', 'timeFrame': '[Time Frame: 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': 'AUCinf: Area under the concentration-time curve from zero up to ∞'}, {'measure': 'Tmax of CKD-348', 'timeFrame': '[Time Frame: 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': 'Tmax: Time to maximum plasma concentration'}, {'measure': 'T1/2 of CKD-348', 'timeFrame': '[Time Frame: 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': 'T1/2: Terminal elimination half-life'}, {'measure': 'AUCt/AUCinf of CKD-348', 'timeFrame': '[Time Frame: 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/AUCinf'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CKD-348'], 'conditions': ['Hypertension and Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-348', 'detailedDescription': 'A Phase 1 Clinical Trial to evaluate the tolerability and pharmacokinetics in healthy adult volunteers after administration of CKD-348 and co-administration of CKD-828, D097, D337.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adult volunteers aged ≥ 19 years\n2. Weight ≥50kg (man) or 45kg (woman), 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 A. Systolic Blood Pressure: 90 to 139 mmHg B. 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 12-lead ECG results at screening.\n6. Those who agree to contraception during the participation of clinical trial\n7. Individuals 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 before the first administration of investigational products.\n3. Those who donated whole blood or apheresis within 2 months or 1 month 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 than below criteria A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) B. 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 study by investigators.\n9. Woman who are pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT04587206', 'briefTitle': 'A Clinical Trial to Evaluate the Pharmacokinetics and Tolerability of CKD-348', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'An Open Label, Randomized, Single Dose, 2-sequence, 4-period, Cross-over Clinical Trial to Evaluate the Pharmacokinetics and Tolerability of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'A86_06BE2007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Sequence 1', 'description': 'Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition\n\nPeriod 2: CKD-348- 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- A single oral dose of 1 tablet under fasting condition', 'interventionNames': ['Drug: CKD-348', 'Drug: CKD-828, D097, D337']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Sequence2', 'description': 'Period 1: CKD-348- 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- 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', 'Drug: CKD-828, D097, D337']}], 'interventions': [{'name': 'CKD-348', 'type': 'DRUG', 'description': 'QD, PO', 'armGroupLabels': ['Experimental: Sequence 1', 'Experimental: Sequence2']}, {'name': 'CKD-828, D097, D337', 'type': 'DRUG', 'description': 'QD, PO', 'armGroupLabels': ['Experimental: Sequence 1', 'Experimental: Sequence2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08779', 'city': 'Seoul', 'state': 'Gwanak-gu', 'country': 'South Korea', 'facility': 'H Plus Yangji Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yook-Hwan Noh, M.D., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}