Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT03726866
Status:
UNKNOWN
Last Update Posted:
2018-11-01
First Post:
2018-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Drug-Drug Interaction Between D326, D337 and CKD-828 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-30', 'studyFirstSubmitDate': '2018-10-30', 'studyFirstSubmitQcDate': '2018-10-30', 'lastUpdatePostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax(Maximum plasma concentration of the drug at steady state)', 'timeFrame': 'at Day 9', 'description': 'PK parameters of D326, D337 and CKD-828'}, {'measure': 'AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)', 'timeFrame': 'at Day 9', 'description': 'PK parameters of D326, D337 and CKD-828'}], 'secondaryOutcomes': [{'measure': 'Tmax(Time to maximum plasma concentration at steady state)', 'timeFrame': 'at Day 9', 'description': 'PK parameters of D326, D337 and CKD-828'}, {'measure': 't1/2(Terminal elimination half-life)', 'timeFrame': 'at Day 9', 'description': 'PK parameters of D326, D337 and CKD-828'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dyslipidemias', 'hypertension', 'Drug-Drug interaction'], 'conditions': ['Dyslipidemias', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'To evaluate pharmacokinetic properties and drug interactions between D326 and D337 co-administered groups, the CKD-828 alone and the total co-administered groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy volunteers aged between ≥ 19 and ≤ 40 years old\n2. Calculated body mass index(BMI) of ≥ 19 and ≤ 28kg/m²\n3. Subject who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods from the date of first administration of Investigational product until completion of the clinical trial\n4. Subject who agree not to provide sperm\n5. Subject who voluntarily agree to participate in this study\n\nExclusion Criteria:\n\n1. Any medical history that may affect drug absorption, distribution, metabolism and excretion\n2. Subject who has a clinically significant disease or history such as endocrine, gastrointestinal, cardiovascular, muscular disease.\n3. Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder\n4. Subject who have received other clinical trial drugs within 90 days prior to the screening visit\n5. Any clinically significant active chronic disease'}, 'identificationModule': {'nctId': 'NCT03726866', 'briefTitle': 'A Study to Investigate Drug-Drug Interaction Between D326, D337 and CKD-828 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A Randomized, Open Label, Repeated-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and Safety Among D326, D337 and CKD-828 in Healthy Subjects', 'orgStudyIdInfo': {'id': '186DDI18020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'Sequence 1', 'interventionNames': ['Drug: Sequence 1']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'Sequence 2', 'interventionNames': ['Drug: Sequence 2']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3', 'description': 'Sequence 3', 'interventionNames': ['Drug: Sequence 3']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4', 'description': 'Sequence 4', 'interventionNames': ['Drug: Sequence 4']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 5', 'description': 'Sequence 5', 'interventionNames': ['Drug: Sequence 5']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 6', 'description': 'Sequence 6', 'interventionNames': ['Drug: Sequence 6']}], 'interventions': [{'name': 'Sequence 1', 'type': 'DRUG', 'description': 'D326, D337 or CKD-828 for 9 days', 'armGroupLabels': ['Sequence 1']}, {'name': 'Sequence 2', 'type': 'DRUG', 'description': 'D326, D337 or CKD-828 for 9 days', 'armGroupLabels': ['Sequence 2']}, {'name': 'Sequence 3', 'type': 'DRUG', 'description': 'D326, D337 or CKD-828 for 9 days', 'armGroupLabels': ['Sequence 3']}, {'name': 'Sequence 4', 'type': 'DRUG', 'description': 'D326, D337 or CKD-828 for 9 days', 'armGroupLabels': ['Sequence 4']}, {'name': 'Sequence 5', 'type': 'DRUG', 'description': 'D326, D337 or CKD-828 for 9 days', 'armGroupLabels': ['Sequence 5']}, {'name': 'Sequence 6', 'type': 'DRUG', 'description': 'D326, D337 or CKD-828 for 9 days', 'armGroupLabels': ['Sequence 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Asan Medical Center, University of Ulsan', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jihwan Oh', 'role': 'CONTACT', 'email': 'jihwan@ckdpharm.com', 'phone': '82-2-6373-0953'}], 'overallOfficials': [{'name': 'Hyeong-Seok Lim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Pharmacology and Therapeutics / Asan Medical Center, University of Ulsan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}