Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT04272502
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2020-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-348 in Healthy Volunteers
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': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2020-02-10', 'studyFirstSubmitQcDate': '2020-02-13', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '0 hour ~ 144 hour', 'description': 'Maximum plasma concentration of the drug'}, {'measure': 'AUCt', 'timeFrame': '0 hour ~ 144 hour', 'description': 'Area under the concentration-time curve from time zero to time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D326 and D337 in healthy adult volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 19 ≤ age ≤ 45\n2. Health Volunteers\n3. Subject who agreeds to participate in this clinical trial voluntarily\n\nExclusion Criteria:\n\n1\\. Subject who cannot participate in a clinical trial based on the PI's judgment"}, 'identificationModule': {'nctId': 'NCT04272502', 'briefTitle': 'Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-348 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-348 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'A86_02BE1902P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A', 'description': 'CKD-828, D326, D337, CKD-F1, CKD-F2', 'interventionNames': ['Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B', 'description': 'CKD-828, D326, D337, CKD-F1, CKD-F2', 'interventionNames': ['Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence C', 'description': 'CKD-828, D326, D337, CKD-F1, CKD-F2', 'interventionNames': ['Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337']}], 'interventions': [{'name': 'CKD-348 F1, CKD-348 F2, CKD-828, D326, D337', 'type': 'DRUG', 'description': 'Each arm has a different order for taking IP', 'armGroupLabels': ['Sequence A', 'Sequence B', 'Sequence C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}