Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-02-24 @ 8:47 AM
Study NCT ID:
NCT06932705
Status:
RECRUITING
Last Update Posted:
2025-04-17
First Post:
2025-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A
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': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2025-04-10', 'studyFirstSubmitQcDate': '2025-04-10', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum concentration of drug in plasma (Cmax)', 'timeFrame': 'pre-dose (0hour) to 72hours', 'description': 'Cmax of PA-111'}, {'measure': 'Area under the plasma concentration-time curve during dosing interval (AUCt)', 'timeFrame': 'pre-dose (0hour) to 72hours', 'description': 'AUCt of PA-111'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mixed Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 in healthy subjects.', 'detailedDescription': 'The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of PA-111 compared with coadministration PA-111A in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight equal to or greater than 50kg (Female 45kg) and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit\n* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit\n\nExclusion Criteria:\n\n* Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration\n* Other exclusions applied'}, 'identificationModule': {'nctId': 'NCT06932705', 'briefTitle': 'A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A', 'organization': {'class': 'INDUSTRY', 'fullName': 'Addpharma Inc.'}, 'officialTitle': 'An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of PA-111 Compared to PA-111A in Healthy Adult Volunteers Under Fed State Conditions', 'orgStudyIdInfo': {'id': 'PA-111BE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A (RT)', 'description': 'Period 1: Reference (PA-111A), Period 2: Test (PA-111)', 'interventionNames': ['Drug: PA-111', 'Drug: PA-111A']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence A (TR)', 'description': 'Period 1: Test (PA-111), Period 2: Reference (PA-111A),', 'interventionNames': ['Drug: PA-111', 'Drug: PA-111A']}], 'interventions': [{'name': 'PA-111', 'type': 'DRUG', 'description': 'PA-111 1Tab., Per Oral', 'armGroupLabels': ['Sequence A (RT)', 'Sequence A (TR)']}, {'name': 'PA-111A', 'type': 'DRUG', 'description': 'PA-111A 1Capsule., Per Oral', 'armGroupLabels': ['Sequence A (RT)', 'Sequence A (TR)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'SeungHyun Kang', 'role': 'CONTACT', 'email': 'juspa@newyjh.com', 'phone': '+82-70-4665-9490'}], 'facility': 'H Plus Yangji Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'JeongEun Park', 'role': 'CONTACT', 'email': 'parkje@addpharma.co.kr', 'phone': '+82-31-891-6989'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Addpharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}