Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT03444402
Status:
COMPLETED
Last Update Posted:
2018-05-24
First Post:
2018-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Compare PK and Safety of CKD-381 and D026 in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-22', 'studyFirstSubmitDate': '2018-02-06', 'studyFirstSubmitQcDate': '2018-02-19', 'lastUpdatePostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state)', 'timeFrame': '0~24h', 'description': 'Evaluation PK esomeprazole after multiple dose'}], 'secondaryOutcomes': [{'measure': 'Cmax,ss(Maximum concentration of drug in plasma at steady state)', 'timeFrame': '0~24h', 'description': 'Evaluation PK esomeprazole after multiple dose'}, {'measure': 'Tmax,ss(Time to maximum plasma concentration at steady state)', 'timeFrame': '0~24h', 'description': 'Evaluation PK esomeprazole after multiple dose'}, {'measure': 't1/2(Terminal elimination half-life)', 'timeFrame': '0~24h', 'description': 'Evaluation PK esomeprazole after multiple dose'}, {'measure': 'R(Accumulation ratio)', 'timeFrame': '0~24h', 'description': 'Evaluation PK esomeprazole after multiple dose'}, {'measure': 'CLss/F(Apparent Clearance at steady state)', 'timeFrame': '0~24h', 'description': 'Evaluation PK esomeprazole after multiple dose'}, {'measure': 'Vss/F(Apparent Volume of distribution at steady state)', 'timeFrame': '0~24h', 'description': 'Evaluation PK esomeprazole after multiple dose'}, {'measure': 'Cmax(Maximum concentration of drug in plasma)', 'timeFrame': '0~24h', 'description': 'Evaluation PK esomeprazole after single dose'}, {'measure': 'AUClast(Area under the plasma drug concentration-time curve from 0 to last)', 'timeFrame': '0~24h', 'description': 'Evaluation PK esomeprazole after single dose'}, {'measure': 'Tmax(Time to maximum plasma concentration)', 'timeFrame': '0~24h', 'description': 'Evaluation PK esomeprazole after single dose'}, {'measure': 't1/2(Terminal elimination half-life)', 'timeFrame': '0~24h', 'description': 'Evaluation PK esomeprazole after single dose'}, {'measure': 'CL/F(Apparent clearance)', 'timeFrame': '0~24h', 'description': 'Evaluation PK esomeprazole after single dose'}, {'measure': 'Vd/F(Apparent volume of distribution)', 'timeFrame': '0~24h', 'description': 'Evaluation PK esomeprazole after single dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CKD-381', 'Nexium'], 'conditions': ['GERD']}, 'descriptionModule': {'briefSummary': 'A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects', 'detailedDescription': 'A randomized, open-label, multiple-dose, and three-way cross over clinical trial to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Between 19 aged and 50 aged in healthy male adult\n2. Body weight more than 55kg\n3. Body Mass Index more than 18.5 and under 25\n\nExclusion Criteria:\n\n1. Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease.\n2. Have a gastrointestinal disease history that can effect drug absorption or surgery.\n3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family.'}, 'identificationModule': {'nctId': 'NCT03444402', 'briefTitle': 'A Study to Compare PK and Safety of CKD-381 and D026 in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A Randomized, Open-label, Multiple-dose, and Three-way Crossover Clinical Trial to Compare Pharmacokinetics and Safety of CKD-381 and D026 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': '173HPS17013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Period 1: Test drug(CKD-381 formulation I), Period 2: Test drug(CKD-381 formulation II), Period 3: Reference drug(D026)', 'interventionNames': ['Drug: CKD-381(formulation I)', 'Drug: CKD-381(formulation II)', 'Drug: D026(Nexium 40mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Period 1: Test drug(CKD-381 formulation II), Period 2: Reference drug(D026), Period 3: Test drug(CKD-381 formulation I)', 'interventionNames': ['Drug: CKD-381(formulation I)', 'Drug: CKD-381(formulation II)', 'Drug: D026(Nexium 40mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'Period 1: Reference drug(D026), Period 2: Test drug(CKD-381 formulation I), Period 3: Test drug(CKD-381 formulation II)', 'interventionNames': ['Drug: CKD-381(formulation I)', 'Drug: CKD-381(formulation II)', 'Drug: D026(Nexium 40mg)']}], 'interventions': [{'name': 'CKD-381(formulation I)', 'type': 'DRUG', 'description': '1 tablet administered before the breakfast during 7 days', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}, {'name': 'CKD-381(formulation II)', 'type': 'DRUG', 'description': '1 tablet administered before the breakfast during 7 days', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}, {'name': 'D026(Nexium 40mg)', 'type': 'DRUG', 'description': '1 tablet administered before the breakfast during 7 days', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyung Sang Yu, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}