Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-25 @ 2:41 PM
Study NCT ID:
NCT06889350
Status:
COMPLETED
Last Update Posted:
2025-07-31
First Post:
2025-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety of HD-P023 and Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C579035', 'term': '3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2025-03-16', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve (AUCt) of Teneligliptin and Empagliflozin', 'timeFrame': '72 hours'}, {'measure': 'Peak Plasma Concentration (Cmax) of Teneligliptin and Empagliflozin', 'timeFrame': '72 hours'}], 'secondaryOutcomes': [{'measure': 'AUC∞ of Teneligliptin and Empagliflozin', 'timeFrame': '72 hours'}, {'measure': 'AUCt/AUC∞ of Teneligliptin and Empagliflozin', 'timeFrame': '72 hours'}, {'measure': 'Tmax of Teneligliptin and Empagliflozin', 'timeFrame': '72 hours'}, {'measure': 'VZ/F of Teneligliptin and Empagliflozin', 'timeFrame': '72 hours'}, {'measure': 'CL/F of Teneligliptin and Empagliflozin', 'timeFrame': '72 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the pharmacokinetics and safety of HD-P023 and coadministration of Teneligliptin and Empagliflozin in healthy adult volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are 19 years or older on screening\n* Signed informed consent\n* Healthy Volunteer\n* Other inclusion applies\n\nExclusion Criteria:\n\n* Clinically relevant/significant findings as evaluated by the investigator\n* Other exclusion applied'}, 'identificationModule': {'nctId': 'NCT06889350', 'briefTitle': 'Pharmacokinetics and Safety of HD-P023 and Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Handok Inc.'}, 'officialTitle': 'A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of HD-P023 in Comparison With Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'HD-MP-108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HD-P023', 'description': 'One tablet of HD-P023 by oral', 'interventionNames': ['Drug: HD-P023']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Co-administration of Teneligliptin and Empagliflozin High', 'description': 'One tablet each of Teneligliptin and Empagliflozin High by oral', 'interventionNames': ['Drug: Teneligliptin', 'Drug: Empagliflozin High']}], 'interventions': [{'name': 'HD-P023', 'type': 'DRUG', 'description': 'Single dose administration of HD-P023', 'armGroupLabels': ['HD-P023']}, {'name': 'Teneligliptin', 'type': 'DRUG', 'description': 'Single does administration of Teneligliptin and Empagliflozin High', 'armGroupLabels': ['Co-administration of Teneligliptin and Empagliflozin High']}, {'name': 'Empagliflozin High', 'type': 'DRUG', 'description': 'Single does administration of Teneligliptin and Empagliflozin High', 'armGroupLabels': ['Co-administration of Teneligliptin and Empagliflozin High']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08779', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'H Plus Yangji Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Handok Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}