Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT01493856
Status:
COMPLETED
Last Update Posted:
2012-04-04
First Post:
2011-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068557', 'term': 'Olmesartan Medoxomil'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-02', 'studyFirstSubmitDate': '2011-12-13', 'studyFirstSubmitQcDate': '2011-12-14', 'lastUpdatePostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUClast', 'timeFrame': '18 time points up to 72 hours'}, {'measure': 'Cmax', 'timeFrame': '18 time points up to 72 hours'}], 'secondaryOutcomes': [{'measure': 'AUCinf', 'timeFrame': '18 time points up to 72 hours'}, {'measure': 'T1/2', 'timeFrame': '18 time points up to 72 hours'}, {'measure': '%AUCextra', 'timeFrame': '18 time points up to 72 hours'}, {'measure': 'Tmax', 'timeFrame': '18 time points up to 72 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and pharmacokinetic characteristics of combination of rosuvastatin and CS-866 and DWJ1276 alone.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adult male volunteers aged 20 to 50 years\n2. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints\n\nExclusion Criteria:\n\n1. A subject who had any allergic history to any drug.\n2. A subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, genitourinary, psychology, ophthalmic, dermatology and gastrointestinal function or other significant diseases\n3. History or suspicion of current drug abuse\n4. A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication\n\n * Within 1 month: drug known CYP inducer or inhibitor\n * Within 2 weeks: Prescribed or herbal medicine\n * Within 1 weeks: OTC medicine\n * Within 2 days: Consumption of caffeine\n5. A subject who had participated in any other clinical study within the last 2 weeks\n6. A subject from whom over 400mL of blood was sampled(whole blood donation) within last 2 weeks or plasma/platelet donation within 1 month.'}, 'identificationModule': {'nctId': 'NCT01493856', 'briefTitle': 'A Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Randomized, Open Label, Single-Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276 in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'DW_DWJ1276002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rosuvastatin+Olmesartan', 'description': 'single dose of Rosuvastatin 20mg and olmesartan medoxomil(CS-866) 40mg', 'interventionNames': ['Drug: Cresto', 'Drug: Olmetec']}, {'type': 'EXPERIMENTAL', 'label': 'DWJ1276', 'description': 'Single dose of DWJ1276', 'interventionNames': ['Drug: DWJ1276']}], 'interventions': [{'name': 'Cresto', 'type': 'DRUG', 'description': 'tablet, rosuvastatin 20mg', 'armGroupLabels': ['Rosuvastatin+Olmesartan']}, {'name': 'Olmetec', 'type': 'DRUG', 'description': 'tablet, olmesartan medoxomil(CS-866) 40mg', 'armGroupLabels': ['Rosuvastatin+Olmesartan']}, {'name': 'DWJ1276', 'type': 'DRUG', 'description': 'tablet, Rosuvastatin 20mg and olmesartan medoxomil 40mg', 'armGroupLabels': ['DWJ1276']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Health System (Yuhs)', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyungsoo Park, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'YONSEI UNIVERSITY HEALTH SYSTEM (YUHS)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}