Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-18 @ 12:42 PM
Study NCT ID:
NCT01501435
Status:
COMPLETED
Last Update Posted:
2017-01-02
First Post:
2011-12-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Compare Safety and Pharmacokinetic Properties of CJ-30039 and Lipidil Supra
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C006012', 'term': 'fenofibric acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-29', 'studyFirstSubmitDate': '2011-12-24', 'studyFirstSubmitQcDate': '2011-12-28', 'lastUpdatePostDateStruct': {'date': '2017-01-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax) of fenofibric acid', 'timeFrame': 'up to 48 hours'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve (AUC) of fenofibric acid', 'timeFrame': 'up to 48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safety', 'Pharmacokinetics'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To investigate the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra', 'detailedDescription': 'Study objectives\n\n* To compare the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra after a single oral administration in healthy male volunteers.\n* To evaluate the food-effect on pharmacokinetics of CJ-30039 after a single oral administration in healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male volunteers in the age between 20 and 55 years old\n* BMI(Body Mass Index) in the range of 18.5 to 25kg/m2\n* Subject with no history of any significant chronic disease\n\nExclusion Criteria:\n\n* History of clinically significant allergies, including fenofibric acid or Fenofibrate\n* History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease\n* History of surgery except or gastrointestinal disease which might significantly change absorption of medicines\n* Clinical laboratory test values are outside the accepted normal range\n\n * AST(ASpartate Transaminase), ALT(ALanine Transaminase)( \\> 1.25 times to normal range\n * Total bilirubin \\> 1.5 times to normal range\n * BUN(Blood Urea Nitrogen) \\> 25 mg/dL or Creatinine \\> 1.4 mg/dL\n * CK(Creatine Kinase) \\> 1.25 times to normal range\n* Estimated GFR(Glomerular Filtration Rate) \\< 80 mL/min/1.73m2\n* Clinically significant vital sign\n\n * SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 150 mmHg\n * DBP(Diastolic Blood Pressure) ≤ 50 mmHg or DBP ≥ 100 mmHg\n* History of drug abuse or positive urine screen for drugs\n* History of caffeine, alcohol, smoking abuse\n\n * caffeine \\> 5 cups/day\n * alcohol \\> 201g/week\n * smoking \\> 10 cigarettes/day\n* Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 7 days before dosing\n* Participated in a previous clinical trial within 60 days prior to dosing\n* Donated blood within 60 days prior to dosing'}, 'identificationModule': {'nctId': 'NCT01501435', 'briefTitle': 'To Compare Safety and Pharmacokinetic Properties of CJ-30039 and Lipidil Supra', 'organization': {'class': 'INDUSTRY', 'fullName': 'HK inno.N Corporation'}, 'officialTitle': 'A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study to Compare the Pharmacokinetics of CJ-30039 and Lipidil Supra and to Investigate Food-effect on Pharmacokinetics of CJ-30039', 'orgStudyIdInfo': {'id': 'CJ_FEN_101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CJ-30039', 'description': 'Incrementally Modified Drugs of fenofibric acid', 'interventionNames': ['Drug: CJ-30039']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fenofibric acid', 'description': 'Greencross Lipidil Supra 160mg', 'interventionNames': ['Drug: fenofibric acid']}], 'interventions': [{'name': 'CJ-30039', 'type': 'DRUG', 'otherNames': ['Incrementally Modified Drugs of fenofibric acid'], 'description': 'single dose', 'armGroupLabels': ['CJ-30039']}, {'name': 'fenofibric acid', 'type': 'DRUG', 'otherNames': ['Greencross Lipidil Supra 160mg'], 'description': 'single dose', 'armGroupLabels': ['fenofibric acid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei university severance hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Min-su Park, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HK inno.N Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}