Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-02-25 @ 12:57 AM
Study NCT ID:
NCT03629067
Status:
COMPLETED
Last Update Posted:
2019-01-10
First Post:
2018-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-08', 'studyFirstSubmitDate': '2018-08-09', 'studyFirstSubmitQcDate': '2018-08-09', 'lastUpdatePostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '0~144hours after Medication', 'description': 'Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma'}], 'secondaryOutcomes': [{'measure': 'AUCinf', 'timeFrame': '0~144hours after medication', 'description': '"Area under the plasma concentration versus time curve " of Fimasartan, Amlodipine, Hydrochlorothiazide'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension'], 'conditions': ['Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the Pharmacokinetics and safety/tolerability between Fimasartan/Amlodipine/Hydrochlorothiazide and co administration of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A healthy adults aged 19-50 years\n\nExclusion Criteria:\n\n* History or presence of clinically significant medical or psychiatric condition or disease\n* Hypersensitivity to ingredient of IP and other medication, food\n* Participation in any other study within 3months\n* History of whole blood donation within 2months and Apheresis 1month'}, 'identificationModule': {'nctId': 'NCT03629067', 'briefTitle': 'Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boryung Pharmaceutical Co., Ltd'}, 'officialTitle': 'A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between BR1010 and Co-administration of BR1010-1 and BR1010-2 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'BR1010(BR-FAHC-CT-102)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A', 'description': 'Period 1(Treatment R) - Period 2(Treatment R) - Period 3(Treatment T)\n\nThere will be a 14 washout of days between the each period.', 'interventionNames': ['Drug: Treatment T', 'Drug: Treatment R']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B', 'description': 'Period 1(Treatment R) - Period 2(Treatment T) - Period 3(Treatment R)\n\nThere will be a 14 washout of days between the each period.', 'interventionNames': ['Drug: Treatment T', 'Drug: Treatment R']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence C', 'description': 'Period 1(Treatment T) - Period 2(Treatment R) - Period 3(Treatment R)\n\nThere will be a 14 washout of days between the each period.', 'interventionNames': ['Drug: Treatment T', 'Drug: Treatment R']}], 'interventions': [{'name': 'Treatment T', 'type': 'DRUG', 'otherNames': ['FAH'], 'description': 'Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide', 'armGroupLabels': ['Sequence A', 'Sequence B', 'Sequence C']}, {'name': 'Treatment R', 'type': 'DRUG', 'otherNames': ['FA/H'], 'description': 'Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide', 'armGroupLabels': ['Sequence A', 'Sequence B', 'Sequence C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100-744', 'city': 'Seoul', 'state': 'Jongno-gu', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyung-sang Yu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}