Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-12 @ 10:07 PM
Study NCT ID:
NCT02461004
Status:
COMPLETED
Last Update Posted:
2016-10-17
First Post:
2015-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CKD-391 Pharmacokinetic Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'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': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-13', 'studyFirstSubmitDate': '2015-06-01', 'studyFirstSubmitQcDate': '2015-06-02', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUClast', 'timeFrame': 'up to 96 hours post dose'}, {'measure': 'Cmax', 'timeFrame': 'up to 96 hours post dose'}], 'secondaryOutcomes': [{'measure': 'Tmax', 'timeFrame': 'up to 96 hours post dose'}, {'measure': 'T1/2', 'timeFrame': 'up to 96 hours post dose'}, {'measure': 'AUCinf', 'timeFrame': 'up to 96 hours post dose'}, {'measure': 'Adverse events', 'timeFrame': 'up to 24days post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dyslipidemia', 'CKD-391', 'Atorvastatin', 'Ezetimibe'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.', 'detailedDescription': 'To compare the CKD-391 (Experimental product) to the dose Atorvastatin calcium and Ezetimibe combination in health male subjects is the purpose of this trial.\n\nFollowing are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Bwt \\>=50kg, BMI 18\\~29\n* signed the informed consent form prior to the study participation\n\nExclusion Criteria:\n\n* Clinically significant disease\n* Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug\n* Clinically significant allergic disease\n* Impossible to taking the institutional standard meal\n* Previously donate whole blood within 60 days or component blood within 20 days\n* Previously participated in other trial within 90 days\n* Continued to be taking caffeine (caffeine \\> 5 cup/day), drinking(alcohol \\> 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette \\> 10 cigarettes per day)during clinical trials\n* An impossible one who participates in clinical trial by investigator's decision including laboratory test result"}, 'identificationModule': {'nctId': 'NCT02461004', 'briefTitle': 'CKD-391 Pharmacokinetic Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of CKD-391 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': '152BE15016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TR group', 'description': 'CKD-391 and combination dose of Atrovastatin and Ezetimibe in order', 'interventionNames': ['Drug: CKD-391', 'Drug: Atrovastatin and Ezetimibe combination therapy']}, {'type': 'EXPERIMENTAL', 'label': 'RT group', 'description': 'combination dose of Atrovastatin and Ezetimibe and CKD-391 in order', 'interventionNames': ['Drug: CKD-391', 'Drug: Atrovastatin and Ezetimibe combination therapy']}], 'interventions': [{'name': 'CKD-391', 'type': 'DRUG', 'description': 'Investigational product is prescribed to all of radomized subjects for two times.', 'armGroupLabels': ['RT group', 'TR group']}, {'name': 'Atrovastatin and Ezetimibe combination therapy', 'type': 'DRUG', 'description': 'Investigational products are prescribed to all of radomized subjects for two times.', 'armGroupLabels': ['RT group', 'TR group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'The Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Ji Young Park, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Korea University Anam Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}