Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-03-27 @ 11:57 PM
Study NCT ID:
NCT00938132
Status:
COMPLETED
Last Update Posted:
2009-10-08
First Post:
2009-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C558933', 'term': 'fimasartan'}, {'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-07', 'studyFirstSubmitDate': '2009-07-10', 'studyFirstSubmitQcDate': '2009-07-10', 'lastUpdatePostDateStruct': {'date': '2009-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'INR AUC, INRmax, INRtmax', 'timeFrame': 'pre-dose, 6, 12, 24, 36, 48, 72, 96, 120, 144 h post-dose on 1 d, 11 d'}], 'secondaryOutcomes': [{'measure': 'AUClast, AUCinf, Cmax ,Tmax, CL/F of S-warfarin and R-warfarin', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 h post-dose on 1 d, 11 d'}]}, 'conditionsModule': {'keywords': ['fimasartan', 'drug interaction'], 'conditions': ['Essential Hypertension']}, 'referencesModule': {'references': [{'pmid': '26257511', 'type': 'DERIVED', 'citation': 'Choi Y, Han H, Shin D, Lim KS, Yu KS. Comparison of the pharmacokinetics and tolerability of HCP1004 (a fixed-dose combination of naproxen and esomeprazole strontium) and VIMOVO(R) (a marketed fixed-dose combination of naproxen and esomeprazole magnesium) in healthy volunteers. Drug Des Devel Ther. 2015 Jul 31;9:4127-35. doi: 10.2147/DDDT.S86725. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of Fimarsartan on pharmacodynamics, pharmacokinetics, and the safety of warfarin in healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 20 - 40 years\n* sex: male\n* body weight: greater than 55 kg\n* written informed consent\n\nExclusion Criteria:\n\n* known allergy to Fimasartan and warfarin\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* positive drug or alcohol screening\n* smokers of 10 or more cigarettes per day 3 month ago\n* participation in a clinical trial during the last 2 months prior to the start of the study'}, 'identificationModule': {'nctId': 'NCT00938132', 'briefTitle': 'A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boryung Pharmaceutical Co., Ltd'}, 'officialTitle': 'A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'A657-BR-CT-108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fimasartan', 'interventionNames': ['Drug: fimasartan, warfarin']}], 'interventions': [{'name': 'fimasartan, warfarin', 'type': 'DRUG', 'description': 'Warfarin(1d) Fimasartan(8d-16d) Fimasartan + Warfarin(11d)', 'armGroupLabels': ['Fimasartan']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Choi, Director', 'oldOrganization': 'Boryung Pharm Co., Inc.'}}}}