Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:33 PM
Study NCT ID:
NCT07297693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Volunteers
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': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCt', 'timeFrame': '0~72 hours', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'Cmax', 'timeFrame': '0~72 hours', 'description': 'Pharmacokinetic evaluation'}], 'secondaryOutcomes': [{'measure': 'Ka', 'timeFrame': '0~72 hours', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'Concentration/Cmax_%', 'timeFrame': '0~72 hours', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'AUCinf', 'timeFrame': '0~72 hours', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'AUCt/AUCinf', 'timeFrame': '0~72 hours', 'description': 'Pharmacokinetic evaluation'}, {'measure': 'Tmax', 'timeFrame': '0~72 hours', 'description': 'Pharmacokinetic evaluation'}, {'measure': 't1/2', 'timeFrame': '0~72 hours', 'description': 'Pharmacokinetic evaluation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2503 and HCP1306 in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19\\~64 years in healthy volunteers\n* 18 kg/m\\^2 ≤ BMI ≤ 30 kg/m\\^2, weight(men) ≥55kg / weight(women) ≥45kg\n* Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 14 days after the administration of the last investigational drug\n* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial\n\nExclusion Criteria:\n\n* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study\n* Subjects who judged ineligible by the investigator'}, 'identificationModule': {'nctId': 'NCT07297693', 'briefTitle': 'A Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2-period, Crossover Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'HM-RIZE-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': '* Period1 : HCP1306\n* Period2 : HIP2503', 'interventionNames': ['Drug: HIP2503', 'Drug: HCP1306']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': '* Period 1 : HIP2503\n* Period 2 : HCP1306', 'interventionNames': ['Drug: HIP2503', 'Drug: HCP1306']}], 'interventions': [{'name': 'HIP2503', 'type': 'DRUG', 'description': 'Take 1 orally disintegrating tablet once per period', 'armGroupLabels': ['Arm 1', 'Arm 2']}, {'name': 'HCP1306', 'type': 'DRUG', 'description': 'Take 1 tablet once per period', 'armGroupLabels': ['Arm 1', 'Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08779', 'city': 'Seoul', 'state': 'Gwanak-gu', 'country': 'South Korea', 'contacts': [{'name': 'Eun Jung Lee Project Manager', 'role': 'CONTACT', 'email': 'm3202@newyjh.com', 'phone': '+82-70-4665-9479'}, {'name': 'Hee Ju Hong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'H plus Yangji Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jee Won Shon', 'role': 'CONTACT', 'email': 'jeewon.shon@hanmi.co.kr', 'phone': '+82-2-410-9037'}], 'overallOfficials': [{'name': 'Hee Ju Hong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H Plus Yangji Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}