Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-03-13 @ 4:25 AM
Study NCT ID:
NCT01353404
Status:
COMPLETED
Last Update Posted:
2012-12-18
First Post:
2011-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg)
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': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-16', 'studyFirstSubmitDate': '2011-05-12', 'studyFirstSubmitQcDate': '2011-05-12', 'lastUpdatePostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg)', 'timeFrame': '23 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperlipidemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg) in single dose oral administration.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults 20-50 years of age\n* Weight more than 55kg and within ±20% IBW(Ideal Body Weight)\n* Voluntary written informed consent\n\nExclusion Criteria:\n\n* History or presence of significant renal, neurologic, pulmonary, endocrine, hematology, oncology, urologic, cardiovascular, musculoskeletal or psychiatric disease\n* Drug allergies to fenofibrate\n* Recent history or evidence of drug abuse\n* Recent participation(within 2months) in other clinical studies\n* Recent donation of blood(within 2months) or plasma(within 1months)'}, 'identificationModule': {'nctId': 'NCT01353404', 'briefTitle': 'Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Samyang Biopharmaceuticals Corporation'}, 'officialTitle': 'Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg) in Normal Healthy Subjects', 'orgStudyIdInfo': {'id': 'SYO0805'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fenofibrate 65mg, fed condition, per oral', 'interventionNames': ['Drug: Sequence 1', 'Drug: Sequence 2', 'Drug: Seqeunce 3', 'Drug: Sequence 4', 'Drug: Sequence 5', 'Drug: Sequence 6']}, {'type': 'EXPERIMENTAL', 'label': 'fenofibrate 65mg, fasting condition, per oral', 'interventionNames': ['Drug: Sequence 1', 'Drug: Sequence 2', 'Drug: Seqeunce 3', 'Drug: Sequence 4', 'Drug: Sequence 5', 'Drug: Sequence 6']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fenofibrate 160mg, fed condition, per oral', 'interventionNames': ['Drug: Sequence 1', 'Drug: Sequence 2', 'Drug: Seqeunce 3', 'Drug: Sequence 4', 'Drug: Sequence 5', 'Drug: Sequence 6']}], 'interventions': [{'name': 'Sequence 1', 'type': 'DRUG', 'description': 'fenofibrate 65mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral', 'armGroupLabels': ['fenofibrate 160mg, fed condition, per oral', 'fenofibrate 65mg, fasting condition, per oral', 'fenofibrate 65mg, fed condition, per oral']}, {'name': 'Sequence 2', 'type': 'DRUG', 'description': 'fenofibrate 65mg, fed condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral', 'armGroupLabels': ['fenofibrate 160mg, fed condition, per oral', 'fenofibrate 65mg, fasting condition, per oral', 'fenofibrate 65mg, fed condition, per oral']}, {'name': 'Seqeunce 3', 'type': 'DRUG', 'description': 'fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fed condition, per oral', 'armGroupLabels': ['fenofibrate 160mg, fed condition, per oral', 'fenofibrate 65mg, fasting condition, per oral', 'fenofibrate 65mg, fed condition, per oral']}, {'name': 'Sequence 4', 'type': 'DRUG', 'description': 'fenofibrate 65mg, fasting condition, per oral → fenofibrate 65mg, fed condition, per oral → fenofibrate 160mg, fed condition, per oral', 'armGroupLabels': ['fenofibrate 160mg, fed condition, per oral', 'fenofibrate 65mg, fasting condition, per oral', 'fenofibrate 65mg, fed condition, per oral']}, {'name': 'Sequence 5', 'type': 'DRUG', 'description': 'fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral', 'armGroupLabels': ['fenofibrate 160mg, fed condition, per oral', 'fenofibrate 65mg, fasting condition, per oral', 'fenofibrate 65mg, fed condition, per oral']}, {'name': 'Sequence 6', 'type': 'DRUG', 'description': 'fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral → fenofibrate 65mg, fed condition, per oral', 'armGroupLabels': ['fenofibrate 160mg, fed condition, per oral', 'fenofibrate 65mg, fasting condition, per oral', 'fenofibrate 65mg, fed condition, per oral']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Clinical Research Institute, Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyung-Sang Yu, M.D., Ph.D., M.B.A.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Institute, Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samyang Biopharmaceuticals Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}