Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT01455558
Status:
COMPLETED
Last Update Posted:
2011-10-20
First Post:
2011-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetic Comparison of Cilostazol SR and IR Formulations in Healthy Korean Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-18', 'studyFirstSubmitDate': '2011-10-14', 'studyFirstSubmitQcDate': '2011-10-18', 'lastUpdatePostDateStruct': {'date': '2011-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Profile of Pharmacokinetics', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose for test drug; 0, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 15, 16, 18, 20, 22, 24, 36, 48, 72 hours post-dose for reference drug', 'description': 'Cmax, Area Under Curve'}]}, 'conditionsModule': {'keywords': ['Pharmacokinetics'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '22129569', 'type': 'DERIVED', 'citation': 'Lee D, Lim LA, Jang SB, Lee YJ, Chung JY, Choi JR, Kim K, Park JW, Yoon H, Lee J, Park MS, Park K. Pharmacokinetic comparison of sustained- and immediate-release oral formulations of cilostazol in healthy Korean subjects: a randomized, open-label, 3-part, sequential, 2-period, crossover, single-dose, food-effect, and multiple-dose study. Clin Ther. 2011 Dec;33(12):2038-53. doi: 10.1016/j.clinthera.2011.10.024. Epub 2011 Nov 29.'}]}, 'descriptionModule': {'briefSummary': "This study investigates safety and pharmacokinetic comparison of Pacific Pharma's PP-101 SR (test formulation) and Otsuka's Pletaal® IR (reference formulation) for single and multiple doses and food effects on Pacific Pharma's PP-101 SR in healthy volunteers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male or female volunteers between the ages of 19 and 55 and within 20% of their ideal body weight, without congenital abnormality or chronic disease\n* Female subjects showing positive results on a serum pregnancy test before the study, and those who were of childbearing potential agreed to use one of the following medically accepted methods of contraception during the entire period of the study: abstinence, documented tubal ligation at least 1 year before enrollment in the study, documented placement of an intrauterine device with a proven failure rate of \\<1% per year, or double barrier methods (a spermicide plus a male condom or female diaphragm).\n\nExclusion Criteria:\n\n* History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;\n* Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;\n* Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;\n* Use of any substance that could induce CYP3A4 synthesis (eg, St. John's wort, other herbal medications)."}, 'identificationModule': {'nctId': 'NCT01455558', 'briefTitle': 'Safety and Pharmacokinetic Comparison of Cilostazol SR and IR Formulations in Healthy Korean Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Severance Hospital'}, 'orgStudyIdInfo': {'id': 'PCF_PP-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cilostazol', 'interventionNames': ['Drug: Pletaal']}], 'interventions': [{'name': 'Pletaal', 'type': 'DRUG', 'description': 'Part 1: a single dose of the SR (200mg x 1 tablet, QD) and IR (100mg x 2 tablets, BID) formulation of cilostazol orally 7 days apart in a fasted state\n\nPart 2: a single dose of the SR (200mg x 1 tablet, QD) formulation of cilostazol 7 days apart in a fasted and a fed state\n\nPart 3: multiple doses of the two formulations for eight consecutive days 21 days apart', 'armGroupLabels': ['Cilostazol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kyungsoo Park', 'investigatorAffiliation': 'Severance Hospital'}}}}