Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-02-22 @ 6:43 PM
Study NCT ID:
NCT03632668
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2018-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Pharmacokinetic Interaction Between AD-2071 and AD-2072
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2018-08-13', 'studyFirstSubmitQcDate': '2018-08-13', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration', 'timeFrame': 'pre-dose to 24 hours', 'description': 'Cmax of the total ingredient of AD-2071 and AD-2072'}, {'measure': 'Area under the plasma concentration versus time curve', 'timeFrame': 'pre-dose to 24 hours', 'description': 'AUCtau of the total ingredient of AD-2071 and AD-20172'}], 'secondaryOutcomes': [{'measure': 'Time to reach Cmax', 'timeFrame': 'pre-dose to 24 hours', 'description': 'Tmax of the total ingredient of AD-2071 and AD-2072'}, {'measure': 'Elimination half-life', 'timeFrame': 'pre-dose to 24 hours', 'description': 't1/2 of the total ingredient of AD-2071 and AD-2072'}, {'measure': 'Clearance', 'timeFrame': 'pre-dose to 24 hours', 'description': 'CL/F of the total ingredient of AD-2071 and AD-2072'}, {'measure': 'Volume of distribution', 'timeFrame': 'pre-dose to 24 hours', 'description': 'Vd/F of the total ingredient of AD-2071 and AD-2072'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'From Day 1 up to Day 46', 'description': 'Incidence rate of adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperlipidemias', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2071 and AD-2072 in healthy male volunteers.', 'detailedDescription': 'To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the administration of AD-2071 and AD-2072.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male between 19 and 50 years of age at the time of screening\n* Weight between 50 kg and 90 kg and body mass index (BMI) between 18.0 kg/m2 and 27.0 kg/m2\n\nExclusion Criteria:\n\n* Clinically significant disease or history of clinically significant disease such as liver, kidney, nervous system, respiratory, endocrine\\*hematologic, cardiovascular, urinary, psychiatric\n* Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery\n* HDL values less than 35 mg/dL\n* AST, ALT values over than 1.5 times of ULN at screening\n* A person who has a history of drug abuse or who has positive result for an abuse drug in a urine screening test'}, 'identificationModule': {'nctId': 'NCT03632668', 'briefTitle': 'Evaluating the Pharmacokinetic Interaction Between AD-2071 and AD-2072', 'organization': {'class': 'INDUSTRY', 'fullName': 'Addpharma Inc.'}, 'officialTitle': 'An Open-label, Two-period, One-sequence, Multiple Dosing Crossover Clinical Trial to Evaluate the Pharmacokinetic Interaction Between AD-2071 and AD-2072 in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'AD-207DDI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'Period 1: AD-2071 10/20mg QD Period 2: AD-2072 80/5mg QD and AD-2071 10/20mg + AD-2072 80/5mg QD', 'interventionNames': ['Drug: AD-2071 10/20mg', 'Drug: AD-2072 80/5mg', 'Drug: AD-2071 10/20mg + AD2072 80/5mg']}], 'interventions': [{'name': 'AD-2071 10/20mg', 'type': 'DRUG', 'description': 'AD-2071 10/20 mg tablet', 'armGroupLabels': ['Sequence 1']}, {'name': 'AD-2072 80/5mg', 'type': 'DRUG', 'description': 'AD-2072 80/5mg tablet', 'armGroupLabels': ['Sequence 1']}, {'name': 'AD-2071 10/20mg + AD2072 80/5mg', 'type': 'DRUG', 'description': 'AD-2071 10/20 mg + AD-2072 80/5mg tablet', 'armGroupLabels': ['Sequence 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'In-Jin Jang, M.D.,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Addpharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}