Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-01-29 @ 9:33 AM
Study NCT ID:
NCT01671020
Status:
COMPLETED
Last Update Posted:
2016-07-01
First Post:
2012-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trials for Single Oral Dose of 60mg Fimasartan and Single IV Infusion of 30mg Fimasartan to Evaluate the Absolute Bioavailability of Kanarb® Tablet (Fimasartan) in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C558933', 'term': 'fimasartan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-29', 'studyFirstSubmitDate': '2012-08-20', 'studyFirstSubmitQcDate': '2012-08-22', 'lastUpdatePostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCinf, AUC, Cmax, Tmax, half-life; t1/2z, AUCt, Vdss, Cl,', 'timeFrame': 'PO : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr, IV : 0.25, 0.5, 0.75, 1, 1.08, 1.17, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fimasartan', 'absolute bioavailability'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Open-label, randomized, crossover clinical trials for single oral dose of 60mg fimasartan and single IV infusion of 30mg fimasartan to evaluate the absolute bioavailability of Kanarb® tablet (fimasartan) in healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age: 20 - 55 years\n* body weight: standard weight(Broca's index, Possible range is plus or minus 20percent)\n* written informed consent\n\nExclusion Criteria:\n\n* known allergy to Fimasartan\n* existing cardiac or hematological diseases\n* existing hepatic and renal diseases\n* existing gastrointestinal diseases\n* acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder\n* abnormal diet which could affect drug absorption or metabolism\n* positive drug or alcohol screening\n* smokers of 10 or more cigarettes per day\n* participation in a clinical trial during the last 90 days prior to the start of the study"}, 'identificationModule': {'nctId': 'NCT01671020', 'briefTitle': 'Clinical Trials for Single Oral Dose of 60mg Fimasartan and Single IV Infusion of 30mg Fimasartan to Evaluate the Absolute Bioavailability of Kanarb® Tablet (Fimasartan) in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boryung Pharmaceutical Co., Ltd'}, 'officialTitle': 'Open-label, Randomized, Crossover Clinical Trials for Single Oral Dose of 60mg Fimasartan and Single IV Infusion of 30mg Fimasartan to Evaluate the Absolute Bioavailability of Kanarb® Tablet (Fimasartan) in Healthy Subjects', 'orgStudyIdInfo': {'id': 'A657-BR-CT-115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '(R)(T)', 'description': 'Period 1: Fimasartan 60mg → Period 2: Fimasartan 30mg', 'interventionNames': ['Drug: Fimasartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(T)(R)', 'description': 'Period 1: Fimasartan 30mg → Period 2: Fimasartan 60mg', 'interventionNames': ['Drug: Fimasartan']}], 'interventions': [{'name': 'Fimasartan', 'type': 'DRUG', 'description': 'Period 1 fisrt administration of fimasartan 60mg Period 2 second administration of fimasartan 30mg', 'armGroupLabels': ['(R)(T)']}, {'name': 'Fimasartan', 'type': 'DRUG', 'description': 'Period 1 first administration of fimasartan 30mg Period 2 second administration of fimasartan 60mg', 'armGroupLabels': ['(T)(R)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'overallOfficials': [{'name': 'Jae-Gook Shin, M.D, Ph.d', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Clinical Pharmacology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}