Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-02-26 @ 4:14 PM
Study NCT ID:
NCT03662620
Status:
COMPLETED
Last Update Posted:
2024-11-12
First Post:
2018-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers
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': 'D000077333', 'term': 'Telmisartan'}, {'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D002752', 'term': 'Chlorthalidone'}, {'id': 'D004341', 'term': 'Drug Evaluation'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D007094', 'term': 'Imides'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D000076722', 'term': 'Drug Development'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, open-label, single-dose, 2-treatment, 2-sequence, 4-period replicate crossover design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2018-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-10', 'studyFirstSubmitDate': '2018-09-03', 'studyFirstSubmitQcDate': '2018-09-05', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUClast of Telmisartan/amlodipine/chlorthalidone', 'timeFrame': '0-168 hrs', 'description': 'AUClast'}, {'measure': 'Cmax of Telmisartan/amlodipine/chlorthalidone', 'timeFrame': '0-168 hrs', 'description': 'Cmax'}], 'secondaryOutcomes': [{'measure': 'AUCinf of Telmisartan/amlodipine/chlorthalidone', 'timeFrame': '0-168 hrs', 'description': 'AUCinf'}, {'measure': 'Tmax of Telmisartan/amlodipine/chlorthalidone', 'timeFrame': '0-168 hrs', 'description': 'Tmax'}, {'measure': 't1/2 of Telmisartan/amlodipine/chlorthalidone', 'timeFrame': '0-168 hrs', 'description': 't1/2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This is a phase 1, randomized, open label, single-dose, replicate crossover clinical trial to compare the safety and pharmacokinetics of YH22162 in healthy male volunteers.\n\nHypothesis: Study drug and comparator drug are showing equal pharmacokinetics.', 'detailedDescription': 'In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64.\n\nIn ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2\n* Who has not suffered from clinically significant disease\n* Provision of signed written informed consent\n\nExclusion Criteria:\n\n* History of and clinically significant disease\n* Administration of other investigational products within 3 months prior to the first dosing\n* Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs'}, 'identificationModule': {'nctId': 'NCT03662620', 'briefTitle': 'Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuhan Corporation'}, 'officialTitle': 'A Randomized, Open-label, Single Dose, Replicate Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'YH22162-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARM1', 'description': 'In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64.', 'interventionNames': ['Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg']}, {'type': 'EXPERIMENTAL', 'label': 'ARM2', 'description': 'In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64.', 'interventionNames': ['Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg']}], 'interventions': [{'name': 'Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg', 'type': 'DRUG', 'otherNames': ['Study drug'], 'description': 'White colored oval three-layer tablet', 'armGroupLabels': ['ARM1', 'ARM2']}, {'name': 'Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg', 'type': 'DRUG', 'otherNames': ['Comparator drug'], 'description': 'White and pink colored oval two-layer tablet', 'armGroupLabels': ['ARM1', 'ARM2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54907', 'city': 'Jeonju', 'state': 'Jeollanam-do', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital'}], 'overallOfficials': [{'name': 'Mingul Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonbuk National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhan Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}