Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT05202405
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2022-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2022-01-09', 'studyFirstSubmitQcDate': '2022-01-09', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': 'pre-dose to 72 hours', 'description': 'Cmax of AD-221'}, {'measure': 'Area Under the Curve in time plot (AUCt)', 'timeFrame': 'pre-dose to 72 hours', 'description': 'AUCt of AD-221'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperlipidemias']}, 'referencesModule': {'references': [{'pmid': '40206873', 'type': 'DERIVED', 'citation': 'Song J, Bae S, Yu KS, Lee S. Comparison of pharmacokinetics of a fixed-dose combination of atorvastatin/ezetimibe 5 mg/10 mg versus separate tablets in healthy subjects. Transl Clin Pharmacol. 2025 Mar;33(1):40-49. doi: 10.12793/tcp.2025.33.e5. Epub 2025 Mar 24.'}]}, 'descriptionModule': {'briefSummary': 'Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-221 in healthy male subjects.', 'detailedDescription': 'The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-221 compared with coadministration AD-221A and AD-221B in healthy male 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 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* 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\n* Subjects who judged ineligible by the investigator'}, 'identificationModule': {'nctId': 'NCT05202405', 'briefTitle': 'A Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Addpharma Inc.'}, 'officialTitle': 'An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B in Healty Adult Volunteers', 'orgStudyIdInfo': {'id': 'AD-221PK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A', 'description': 'Period 1 : Reference Drug(AD-221A and AD-221B) Period 2 : Test Drug(AD-221)', 'interventionNames': ['Drug: AD-221', 'Drug: AD-221A and AD-221B']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B', 'description': 'Period 1 : Test Drug(AD-221) Period 2 : Reference Drug(AD-221A and AD-221B)', 'interventionNames': ['Drug: AD-221', 'Drug: AD-221A and AD-221B']}], 'interventions': [{'name': 'AD-221', 'type': 'DRUG', 'description': 'AD-221 Oral Tablet', 'armGroupLabels': ['Sequence A', 'Sequence B']}, {'name': 'AD-221A and AD-221B', 'type': 'DRUG', 'description': 'AD-221A Oral Tablet + AD-221B Oral Tablet', 'armGroupLabels': ['Sequence A', 'Sequence B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'H+ Yangji Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Addpharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}