Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-30 @ 4:01 AM
Study NCT ID:
NCT00937534
Status:
COMPLETED
Last Update Posted:
2009-11-04
First Post:
2009-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare and Assess the Safety and Pharmacokinetic Characteristics After Oral Administration of Fimasartan (BR-A-657∙K) in Healthy Elderly and Young 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-02', 'studyFirstSubmitDate': '2009-07-06', 'studyFirstSubmitQcDate': '2009-07-10', 'lastUpdatePostDateStruct': {'date': '2009-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax, AUClast, tmax, t1/2', 'timeFrame': '0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fimasartan', 'healthy elderly and young male volunteer', 'pharmacokinetic'], 'conditions': ['Essential Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare and assess the safety and pharmacokinetic characteristics after oral administration of fimasartan (BR-A-657∙K) in healthy elderly and young male volunteers.', '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, single-dosing, parallel Clinical Study to Evaluate pharmacokinetic characteristics after oral administration of fimasartan in healthy elderly and young male volunteers.\n\n22 male healthy volunteers were enrolled during 2 months.\n\nIn part A, 240 mg of fimasartan per day was taken once by younger male healthy volunteers in day 1. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours after administration.\n\nIn part B, 240 mg of hydrochlorothiazide per day was taken once by elderly male healthy volunteers in day 1. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours after administration.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age\n\n * young: 19-45 years\n * elderly: more than 65 years\n* sex: male\n* body weight: greater than 55 kg\n\nExclusion Criteria:\n\n* patients with contraindication to angiotensin II receptor antagonist.\n* patients with a history of liver, renal, gastrointestinal, hematological or cardiac diseases\n* patients with history or diseases which might affect absorption of the drug\n* patients with HIV, type B or C hepatitis\n* smokers of 20 or more cigarettes per day'}, 'identificationModule': {'nctId': 'NCT00937534', 'acronym': 'Fimasartan', 'briefTitle': 'Study to Compare and Assess the Safety and Pharmacokinetic Characteristics After Oral Administration of Fimasartan (BR-A-657∙K) in Healthy Elderly and Young Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boryung Pharmaceutical Co., Ltd'}, 'officialTitle': 'An Open Label, Single-dosing, and Parallel Study in Healthy Elderly and Young Male Volunteers.', 'orgStudyIdInfo': {'id': 'A657-BR-CT-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Part A', 'description': 'Young male healthy volunteer', 'interventionNames': ['Drug: Fimasartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part B', 'description': 'Elderly male healthy volunteer', 'interventionNames': ['Drug: Fimasartan']}], 'interventions': [{'name': 'Fimasartan', 'type': 'DRUG', 'description': 'Fimasartan 240mg/day', 'armGroupLabels': ['Part A', 'Part B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, {'name': 'Seoul National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Choi, Director', 'oldOrganization': 'Boryung Pharm Co., Inc'}}}}