Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-01 @ 4:53 AM
Study NCT ID:
NCT00923533
Status:
COMPLETED
Last Update Posted:
2009-10-08
First Post:
2009-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide 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': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-07', 'studyFirstSubmitDate': '2009-06-16', 'studyFirstSubmitQcDate': '2009-06-17', 'lastUpdatePostDateStruct': {'date': '2009-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC, Cmax, Tmax, CL/F', 'timeFrame': '0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fimasartan', 'Drug interaction'], 'conditions': ['Essential Hypertension']}, 'referencesModule': {'references': [{'pmid': '22727611', 'type': 'DERIVED', 'citation': 'Gu N, Kim BH, Lim KS, Kim SE, Nam WS, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. The effect of fimasartan, an angiotensin receptor type 1 blocker, on the pharmacokinetics and pharmacodynamics of warfarin in healthy Korean male volunteers: a one-sequence, two-period crossover clinical trial. Clin Ther. 2012 Jul;34(7):1592-600. doi: 10.1016/j.clinthera.2012.06.004. Epub 2012 Jun 22.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.', 'detailedDescription': 'Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models.\n\nPhase I study, Fimasartan (BR-A-657-K) 20 mg \\~ 480 mg single dosing with healthy subjects, demonstrated that the Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose.\n\nA open-labeled, multiple-dosing, crossover, parallel Clinical Study to Evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.\n\n34 male healthy volunteers were enrolled during 2 months.\n\nIn part A, 240 mg of fimasartan per day was taken for 1 week. After 7 day washout period, 240 mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours at 7 day and 21 day.\n\nIn part B, 25 mg of hydrochlorothiazide per day was taken for 1 week. After 7 day washout period, 240 mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours at 7 day and 21 day.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 20 - 45 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 hydrochlorothiazide\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\n* 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': 'NCT00923533', 'briefTitle': 'A Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boryung Pharmaceutical Co., Ltd'}, 'officialTitle': 'An Open-label, Multiple-dosing, Crossover, and Parallel Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'A657-BR-CT-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Part A', 'description': 'Fimasartan (7day) Fimasartan + Hydrochlorothiazide (7day)', 'interventionNames': ['Drug: Fimasartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part B', 'description': 'Hydrochlorothiazide (7day) Hydrochlorothiazide + Fimasartan (7day)', 'interventionNames': ['Drug: Hydrochlorothiazide']}], 'interventions': [{'name': 'Fimasartan', 'type': 'DRUG', 'description': 'Fimasartan (7day) Fimasartan + Hydrochlorothiazide (7day)', 'armGroupLabels': ['Part A']}, {'name': 'Hydrochlorothiazide', 'type': 'DRUG', 'description': 'Hydrochlorothiazide (7day) Fimasartan + Hydrochlorothiazide (7day)', 'armGroupLabels': ['Part B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Choi, Director', 'oldOrganization': 'Boryung Pharm Co., Inc.'}}}}