Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-04 @ 9:12 PM
Study NCT ID:
NCT02205151
Status:
COMPLETED
Last Update Posted:
2014-10-15
First Post:
2014-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C558933', 'term': 'fimasartan'}, {'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-13', 'studyFirstSubmitDate': '2014-07-29', 'studyFirstSubmitQcDate': '2014-07-29', 'lastUpdatePostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '(Cmax)', 'timeFrame': '0~144 hour after medication'}, {'measure': '(AUClast)', 'timeFrame': '0~144 hour after medication'}], 'secondaryOutcomes': [{'measure': '(AUCinf)', 'timeFrame': '0~144 hour after medication'}, {'measure': '(tmax)', 'timeFrame': '0~144 hour after medication'}, {'measure': '(t1/2)', 'timeFrame': '0~144 hour after medication'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fimasartan'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets in Healthy Male Volunteers', 'detailedDescription': 'After subjects have signed informed consent voluntarily, they go through screening period for within 21 days.\n\nAs period I, subjects of A Group take fimasartan and amlodipine at 1st day and subjects of B Group take fimasartan/amlodipine combination at 1st day.\n\nAnd then, after wash out for 14 days, as period II, subjects of A Group take fimasartan/amlodipine combination at 15th day and subjects of B Group take fimasartan and amlodipine at 15th day.\n\nAt each period, subjects of A Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total).\n\nAt each period, subjects of B Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy male subject, aged 19- 50 years at screening.\n2. Body weight of ≥ 50 kg and within ± 20% of ideal body weight (IBW)(kg) = {height (cm) - 100} \\* 0.9\n3. Subjects must be able to listen to and understand the detailed statement of informed consent, and willing to decide to participate in the study, follow the study directions and provide written informed consent\n\nExclusion Criteria:\n\n1. History of gastrointestinal disease (i.g., Crohn's disease, active peptic ulcer) or resection operation that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)\n2. History of clinically significant hypersensitivity to study drug, any other drug or additives (yellow no.4).\n3. Subject that is judged inappropriate for participating in the study based on physical examination\n4. The levels of ALT(Aspartate Transaminase), AST (Alanin Transaminase) or total bilirubin \\> 1.5 x the upper limit of normal or eGFR \\< 60 mL/min/1.73m (calculated by MDRD)\n5. Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.\n6. systolic ≥ 140 mmHg or ≤ 100 mmHg, diastolic ≥ 90 mmHg or ≤ 65 mmHg), measured after taking a rest for 5minutes\n7. Take any other study's investigational products within 90 days prior to the first administration of study drug\n8. Donation of whole blood within 60 days prior to the first administration of study drug, or donation of any blood products within 30 days prior to the first administration of study drug\n9. Intake food like Grapefruit juice (\\*e.g., Grapefruit juice ≥ 1L /day) within 7 days prior to administration of study drug\n10. Use of any prescribed drugs or herbal remedies within 14 days, or use of any over-the-counter medication or vitamins within 7 days prior to the first administration of study drug\n11. Positive serologic tests (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)\n12. Subject that is judged inappropriate for participating in the study by an investigator, based any other reason"}, 'identificationModule': {'nctId': 'NCT02205151', 'briefTitle': 'To Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boryung Pharmaceutical Co., Ltd'}, 'officialTitle': 'An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'BR-FAC-CT-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment AB', 'description': 'Treatment A (1 day) → wash-out(14days) → Treatment B (1 day)\n\nTreatment A : Fimasartanm and Amlodipine\n\nTreatment B : Fimasartan/Amlodipine combination', 'interventionNames': ['Drug: Fimasartan', 'Drug: Amlodipine', 'Drug: Fimasartan/Amlodipine combination']}, {'type': 'OTHER', 'label': 'Treatment BA', 'description': 'Treatment B (1 day) → wash-out(14days) → Treatment A (1 day)\n\nTreatment A : Fimasartanm and Amlodipine\n\nTreatment B : Fimasartan/Amlodipine combination', 'interventionNames': ['Drug: Fimasartan', 'Drug: Amlodipine', 'Drug: Fimasartan/Amlodipine combination']}], 'interventions': [{'name': 'Fimasartan', 'type': 'DRUG', 'armGroupLabels': ['Treatment AB', 'Treatment BA']}, {'name': 'Amlodipine', 'type': 'DRUG', 'armGroupLabels': ['Treatment AB', 'Treatment BA']}, {'name': 'Fimasartan/Amlodipine combination', 'type': 'DRUG', 'armGroupLabels': ['Treatment AB', 'Treatment BA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'The Catholic university St. Mary hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'seunghoon han, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Catholic university St. Mary hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kyunghee university hospital A Drug Analytical Laboratory', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}