Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-05 @ 5:50 PM
Study NCT ID:
NCT03639493
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2018-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of CJ-30060 in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068838', 'term': 'Amlodipine, Valsartan Drug Combination'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D000068756', 'term': 'Valsartan'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, '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': '2018-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-19', 'studyFirstSubmitDate': '2018-08-09', 'studyFirstSubmitQcDate': '2018-08-19', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of amlodipine', 'timeFrame': 'Up to 144 hours post-dose'}, {'measure': 'Cmax of valsartan', 'timeFrame': 'Up to 144 hours post-dose'}, {'measure': 'Cmax of rosuvastatin', 'timeFrame': 'Up to 144 hours post-dose'}, {'measure': 'AUClast of amlodipine', 'timeFrame': 'Up to 144 hours post-dose'}, {'measure': 'AUClast of valsartan', 'timeFrame': 'Up to 144 hours post-dose'}, {'measure': 'AUClast of rosuvastatin', 'timeFrame': 'Up to 144 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'AUCinf of amlodipine, valsaran, rosuvastatin', 'timeFrame': 'Up to 144 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Male Subjects']}, 'descriptionModule': {'briefSummary': 'To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg in healthy male volunteers.', 'detailedDescription': 'The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg in healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males aged 20 to 45 years at screening\n* BMI: 18 \\~ 29.9kg/m\\^2\n* Body weight ≥ 50kg\n* Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding\n\nExclusion Criteria:\n\n* Subjects who had a medical history of severe cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological or neuropsychological disease\n* Subjects who have symptoms of an acute disease within 28 days before first administration\n* Subjects who have clinically significant active, chronic disease\n* Subjects who fall under the criteria below in laboratory test\n\n * AST/ALT \\> UNL (upper normal limit) x 2\n * Total bilirubin \\> UNL x 1.5\n * CrCL \\< 50mL/min\n * CPK \\> UNL x 2.5\n* Subjects with clinically significant low blood pressure at screening test (systolic blood pressure is less than 100 mmHg or diastolic blood pressure is less than 60 mmHg)\n* Subjects with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests'}, 'identificationModule': {'nctId': 'NCT03639493', 'briefTitle': 'Bioequivalence Study of CJ-30060 in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'HK inno.N Corporation'}, 'officialTitle': 'An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerabillity of CJ-30060 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'CJ_EXR_103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': '* Period 1: receive Exforge® tab 10/160mg, Crestor® tab 20mg\n* Period 2: receive CJ-30060 10/160/20mg', 'interventionNames': ['Drug: Exforge® tab 10/160mg, Crestor® tab 20mg', 'Drug: CJ-30060 10/160/20mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': '* Period 1: receive CJ-30060 10/160/20mg\n* Period 2: receive Exforge® tab 10/160mg, Crestor® tab 20mg', 'interventionNames': ['Drug: Exforge® tab 10/160mg, Crestor® tab 20mg', 'Drug: CJ-30060 10/160/20mg']}], 'interventions': [{'name': 'Exforge® tab 10/160mg, Crestor® tab 20mg', 'type': 'DRUG', 'description': 'Co-administration of Amlodipine 10mg/ Valsartan 160mg(combination drug) and Rosuvastatin 20mg', 'armGroupLabels': ['Sequence 1', 'Sequence 2']}, {'name': 'CJ-30060 10/160/20mg', 'type': 'DRUG', 'description': 'Fixed-dose combination drug containing Amlodipine 10mg and Valsartan 160mg and Rosuvastatin 20mg', 'armGroupLabels': ['Sequence 1', 'Sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Ji Young Park, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HK inno.N Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}