Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-29 @ 2:42 PM
Study NCT ID:
NCT04081857
Status:
COMPLETED
Last Update Posted:
2019-09-09
First Post:
2019-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Pharmacokinetics and Safety of HCP1704 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-05', 'studyFirstSubmitDate': '2019-09-05', 'studyFirstSubmitQcDate': '2019-09-05', 'lastUpdatePostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of Vildagliptin', 'timeFrame': 'pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'AUClast of Vildagliptin', 'timeFrame': 'pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Cmax of Metformin', 'timeFrame': 'pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'AUClast of Metformin', 'timeFrame': 'pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour', 'description': 'pharmacokinetic evaluation'}], 'secondaryOutcomes': [{'measure': 'AUCinf of Vildagliptin', 'timeFrame': 'pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Tmax of Vildagliptin', 'timeFrame': 'pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 't1/2 of Vildagliptin', 'timeFrame': 'pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'CL/F of Vildagliptin', 'timeFrame': 'pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Vd/F of Vildagliptin', 'timeFrame': 'pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'AUCinf of Metformin', 'timeFrame': 'pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Tmax of Metformin', 'timeFrame': 'pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 't1/2 of Metformin', 'timeFrame': 'pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'CL/F of Metformin', 'timeFrame': 'pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour', 'description': 'pharmacokinetic evaluation'}, {'measure': 'Vd/F of Metformin', 'timeFrame': 'pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour', 'description': 'pharmacokinetic evaluation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health, Subjective']}, 'descriptionModule': {'briefSummary': 'An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HCP1704 in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 19\\~55 years in healthy volunteers\n2. BMI is more than 18.5 kg/m\\^2 , no more than 24.9 kg/m\\^2\n3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing\n\nExclusion Criteria:\n\n1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system\n2. Subjects who judged ineligible by the investigator'}, 'identificationModule': {'nctId': 'NCT04081857', 'briefTitle': 'A Study to Evaluate the Pharmacokinetics and Safety of HCP1704 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'A Randomized, Open-Label, Single-Dose, Crossover Study to Compare Pharmacokinetic Properties and Safety of HCP1704 and HGP1810 in Healthy Adults', 'orgStudyIdInfo': {'id': 'HM-VIME-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'Period 1 : Fasted state + HGP1810 Period 2 : Fasted state + HCP1704', 'interventionNames': ['Drug: HGP1810', 'Drug: HCP1704']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'Period 1 : Fasted state + HCP1704 Period 2 : Fasted state + HGP1810', 'interventionNames': ['Drug: HGP1810', 'Drug: HCP1704']}], 'interventions': [{'name': 'HGP1810', 'type': 'DRUG', 'description': 'HGP1810: Vildagliptin/Metformin', 'armGroupLabels': ['Sequence 1', 'Sequence 2']}, {'name': 'HCP1704', 'type': 'DRUG', 'description': 'HCP1704: Vildagliptin/Metformin', 'armGroupLabels': ['Sequence 1', 'Sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anyang', 'country': 'South Korea', 'facility': 'Metro hospital', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}