Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT07265167
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2025-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study Between YHP2406 and YHR2501 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': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-23', 'studyFirstSubmitDate': '2025-11-23', 'studyFirstSubmitQcDate': '2025-11-23', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma drug concentration-time curve [AUCt]', 'timeFrame': '0-8 hours', 'description': 'Area under the plasma drug concentration-time curve \\[AUCt\\] of Amoxicillin \\& Clavulanic acid'}, {'measure': 'Maximum plasma concentration [Cmax]', 'timeFrame': '0-8 hours', 'description': 'Maximum plasma concentration \\[Cmax\\] of Amoxicillin \\& Clavulanic acid'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]', 'timeFrame': '0-8 Hours', 'description': 'Area under the plasma drug concentration-time curve from time 0 to infinity \\[AUCinf\\] of Amoxicillin \\& Clavulanic acid'}, {'measure': 'Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]', 'timeFrame': '0-8 Hours', 'description': 'Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity \\[AUCt/AUCinf\\] of Amoxicillin \\& Clavulanic acid'}, {'measure': 'Time of peak concentration [Tmax]', 'timeFrame': '0-8 Hours', 'description': 'Time of peak concentration \\[Tmax\\] of Amoxicillin \\& Clavulanic acid'}, {'measure': 'Terminal phase of half-life [t1/2]', 'timeFrame': '0-8 Hours', 'description': 'Terminal phase of half-life \\[t1/2\\] of Amoxicillin \\& Clavulanic acid'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'Bioequivalence'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2406 and YHR2501 in healthy volunteers', 'detailedDescription': '62 healthy subjects will be randomized to one of the 2 groups in the same ratio.\n\nSubjects in group 1 will be administered "comparator" and "YHP2406" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2406" and "comparator" by crossover design on period 1, 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 18-30 kg/m2\n* Those without clinically significant congenital or chronic diseases\n\nExclusion Criteria:\n\n* Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.\n* Others who are judged ineligible to participate in the trial by the principal investigator.\n* Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT07265167', 'briefTitle': 'Bioequivalence Study Between YHP2406 and YHR2501 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuhan Corporation'}, 'officialTitle': 'An Open-label, Randomized, Fasting, Single-dose, Oral Administration, 2- Sequence, 2-period, Crossover Study to Evaluate Bioequivalence Study Between YHP2406 and YHR2501 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'YHP2406-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A(RT)', 'description': '31 subjects, Cross-over, Single dose YHR2501 on period 1, Single dose of YHP2406 on period 2', 'interventionNames': ['Drug: YHP2406', 'Drug: YHR2501']}, {'type': 'EXPERIMENTAL', 'label': 'B(TR)', 'description': '31 subjects, Cross-over, Single dose of YHP2406 on period 1, Single dose of YHR2501 on period 2', 'interventionNames': ['Drug: YHP2406', 'Drug: YHR2501']}], 'interventions': [{'name': 'YHP2406', 'type': 'DRUG', 'description': 'Test drug: YHP2406, Comparator: YHR2501', 'armGroupLabels': ['A(RT)', 'B(TR)']}, {'name': 'YHR2501', 'type': 'DRUG', 'description': 'Test drug: YHP2406, Comparator: YHR2501', 'armGroupLabels': ['A(RT)', 'B(TR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08779', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'H Plus Yangji Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Seoung Hyun Kang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H Plus Yangji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhan Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}