Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT02343250
Status:
COMPLETED
Last Update Posted:
2016-01-13
First Post:
2015-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination With Coadministration of Cilnidipine and Valsartan
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': 'C065927', 'term': 'cilnidipine'}, {'id': 'D000068756', 'term': 'Valsartan'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'lastUpdateSubmitDate': '2016-01-11', 'studyFirstSubmitDate': '2015-01-15', 'studyFirstSubmitQcDate': '2015-01-15', 'lastUpdatePostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUClast', 'timeFrame': '0~24hr'}, {'measure': 'Cmax', 'timeFrame': '0~24hr'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ildong.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan 160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 20 and 40\n* Signed informed consent\n\nExclusion Criteria:\n\n* Has a history of hypersensitivity to IP ingredients\n* Hypertension of hypotension'}, 'identificationModule': {'nctId': 'NCT02343250', 'acronym': 'IDCV', 'briefTitle': 'A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination With Coadministration of Cilnidipine and Valsartan', 'organization': {'class': 'INDUSTRY', 'fullName': 'IlDong Pharmaceutical Co Ltd'}, 'officialTitle': 'A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan 160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'ID-IDCV-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cinidipine/Valsartan tablet', 'description': 'Cinidipine/Valsartan tablet', 'interventionNames': ['Drug: Cilnidipine/Valsartan', 'Drug: Cilnidipine+Valsartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cilnidipine+Valsartan', 'description': 'coadministration of cilinidipine and valsartan', 'interventionNames': ['Drug: Cilnidipine+Valsartan', 'Drug: Cilnidipine/Valsartan']}], 'interventions': [{'name': 'Cilnidipine/Valsartan', 'type': 'DRUG', 'description': 'Cilnidipine 10mg/Valsartan 160mg oral on day1 of 14day cycle', 'armGroupLabels': ['Cinidipine/Valsartan tablet']}, {'name': 'Cilnidipine+Valsartan', 'type': 'DRUG', 'description': 'Cinidipine 10mg+Valsartan 160mg oral on day1 of 14day cycle', 'armGroupLabels': ['Cilnidipine+Valsartan']}, {'name': 'Cilnidipine/Valsartan', 'type': 'DRUG', 'description': 'Cilnidipine 10mg/Valsartan 160mg oral on day1 of 14day cycle', 'armGroupLabels': ['Cilnidipine+Valsartan']}, {'name': 'Cilnidipine+Valsartan', 'type': 'DRUG', 'description': 'Cinidipine 10mg+Valsartan 160mg oral on day1 of 14day cycle', 'armGroupLabels': ['Cinidipine/Valsartan tablet']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kyungsang Yu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IlDong Pharmaceutical Co Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}