Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-08 @ 4:35 PM
Study NCT ID:
NCT06568133
Status:
COMPLETED
Last Update Posted:
2024-08-23
First Post:
2024-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-drug Interaction Study Between UIC201603, and UIC201604
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': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2024-07-23', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma pharmacokinetics(AUCss,τ) of Cilostazol and Active metabolites(OPC-13015, OPC-13213)', 'timeFrame': 'Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h', 'description': 'Area under the serum drug concentration-time curve within a dosing interval at steady state'}, {'measure': 'Plasma pharmacokinetics(Css,max) of Cilostazol and Active metabolites(OPC-13015, OPC-13213)', 'timeFrame': 'Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h', 'description': 'Maximum concentration of drug in serum at steady state'}, {'measure': 'Plasma pharmacokinetics(AUCss,τ) of Rosuvastatin', 'timeFrame': 'Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h', 'description': 'Area under the serum drug concentration-time curve within a dosing interval at steady state'}, {'measure': 'Plasma pharmacokinetics(Css,max) of Rosuvastatin', 'timeFrame': 'Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h', 'description': 'Maximum concentration of drug in serum at steady state'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '39487337', 'type': 'DERIVED', 'citation': 'Kim DH, Hong JH, Jung WT, Nam KY, Roh JS, Lee HJ, Moon J, Kim KY, Jung JG, Sunwoo J. Pharmacokinetic Drug-Drug Interaction between Cilostazol and Rosuvastatin in Healthy Participants. Am J Cardiovasc Drugs. 2025 Mar;25(2):267-276. doi: 10.1007/s40256-024-00686-w. Epub 2024 Nov 2.'}]}, 'descriptionModule': {'briefSummary': 'An open-label, multiple-dosing, two-arms, one-sequence study to evaluate the safety and pharmacokinetics after co-administration of UIC201603 and UIC201604 in healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal Body Weight;\n2. Subjects without congenital disease, chronic disease, symptom or any clinical significance of a physical examination and questionnaires;\n3. Subjects judged as healthy by laboratory tests including blood haematology, biochemistry, urinalysis and serologic tests;\n4. Subjects able to read and understand a written informed consent, and willing to participate in the study.\n5. For women, those who are confirmed not to be pregnant during a health examination\n\nExclusion Criteria:\n\n1. Clinically significant, liver, kidney, nervous system, respiratory system, blood/tumor, urinary system, Mental disorders, especially cardiovascular diseases (e.g. hypertension, angina pectoris, heart failure, myocardial infarction, etc.) Those who have or have a history of diseases related to the endocrine system (diabetes, hyperlipidemia, etc.)\n2. Bleeding (hemophilia, capillary fragility, intracranial hemorrhage, upper digestive tract hemorrhage, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage, etc.) or such predispositions (active peptic ulcer, hemorrhagic stroke within the past 6 months, surgery within the past 3 months, proliferative diabetic retinopathy, uncontrolled Patients with high blood pressure)\n3. Patients with atrial or ventricular displacement, patients with atrial fibrillation or flutter, ventricular tachycardia, ventricular fibrillation, or Patients with multifocal ventricular ectopic beats and patients with prolonged QT interval\n4. Gastrointestinal diseases that may affect the absorption of investigational drugs (Crohn's disease, ulcers) acute or chronic pancreatitis, etc.) or gastrointestinal surgery (however, simple appendectomy or Those with a history of hernia surgery (excluding hernia surgery)\n5. Those with a history of hypersensitivity to Cilostazol or other antiplatelet agents,\n6. Same series as rosuvastatin, atorvastatain, simvastatin, etc. (HMG-CoA Hypersensitivity reaction to the components of reductase inhibitor or clinically significant Those with a history of hypersensitivity reaction\n7. Galactose intolerance, Lapp lactase deficiency lactose deficiency or glucose-galactose malabsorption People with genetic problems such as malabsorption\n8. If PT and aPTT are outside the allowable range (diagnostic laboratory reference values are 11-15 sec, respectively, 22.4-40.4 sec)\n9. Vital signs show systolic blood pressure ≥ 140 mmHg or \\< 90 mmHg, diastolic blood pressure ≥ 95 Either mmHg or \\<60 mmHg, pulse rate ≥100 beats/min. Those who showed included figures\n10. Those with high-density lipoprotein (HDL-cholesterol) less than 35 mg/dL\n11. Those whose serum potassium concentration is less than 3.4 mEq/L or more than 5.5 mEq/L\n12. Have a history of muscle disease or a personal or family history of hereditary muscle abnormalities ruler\n13. Patients with biliary obstructive disease\n14. Unexplained persistent elevation of serum transaminases or three times the upper limit of normal Patients with active liver disease including excess serum transaminase elevations\n15. Patients with severe renal impairment (creatinine clearance calculated by the Cockcroft-Gault equation is 30 Those with less than mL/min)\n16. Those with a history of drug abuse or a positive drug abuse test\n17. Induction of drug metabolizing enzymes such as barbiturates within 1 month before the first administration date and Those who take suppressive drugs or drink excessively\n18. Those who have taken any prescription medicine or herbal medicine within 2 weeks before the first medication date, or any over-the-counter medicine (OTC medicine) or vitamin supplement within 10 days (except, Depending on the investigator's judgment, you may participate in the clinical trial if other conditions are reasonable. has exist)\n19. Participating in another clinical trial or bioequivalence test within 3 months before the first administration date Person who administered clinical trial drug\n20. Donate whole blood within 2 months or component blood within 1 month before the first dose. or received a blood transfusion within 1 month before the first dose\n21. For women, pregnant/nursing or currently using a medically acceptable form of contraception. Those who are not using contraception or are unable to maintain contraception during the clinical trial period\n22. Clinical test performance The investigator may not conduct a clinical trial due to test results or other reasons. Those judged unsuitable for participation"}, 'identificationModule': {'nctId': 'NCT06568133', 'briefTitle': 'Drug-drug Interaction Study Between UIC201603, and UIC201604', 'organization': {'class': 'INDUSTRY', 'fullName': 'Korea United Pharm. Inc.'}, 'officialTitle': 'An Open-label, Multiple-dosing, Two-arms, One-sequence Study to Evaluate the Safety and Pharmacokinetics After Co-administration of UIC201603 and UIC201604 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'KUP-UI022-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'UIC201603 and co-administration of UIC201603 and UIC201604', 'interventionNames': ['Drug: UIC201603 and co-administration of UIC201603 and UIC201604']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': 'UIC201604 and co-administration of UIC201603 and UIC201604', 'interventionNames': ['Drug: UIC201604 and co-administration of UIC201603 and UIC201604']}], 'interventions': [{'name': 'UIC201603 and co-administration of UIC201603 and UIC201604', 'type': 'DRUG', 'description': '* UIC201603 2 Caps/day for 7 days\n* Wash out 7 days\n* UIC201603 2 Caps/day + UIC201604 1 Tabs/day for 7 days', 'armGroupLabels': ['Treatment A']}, {'name': 'UIC201604 and co-administration of UIC201603 and UIC201604', 'type': 'DRUG', 'description': '* UIC201604 1 Tabs/day for 7 days\n* Wash out 7 days\n* UIC201603 2 Caps/day + UIC201604 1 Tabs/day for 7 daysadministration of UIC201603 and UIC201604', 'armGroupLabels': ['Treatment B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}], 'overallOfficials': [{'name': 'Janghee Hong, M.D.,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chungnam National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea United Pharm. Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}