Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-25 @ 7:14 PM
Study NCT ID:
NCT02384720
Status:
UNKNOWN
Last Update Posted:
2016-10-10
First Post:
2015-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Freefol-MCT PKPD in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000375', 'term': 'Aging'}], 'ancestors': [{'id': 'D048788', 'term': 'Growth and Development'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-07', 'studyFirstSubmitDate': '2015-02-24', 'studyFirstSubmitQcDate': '2015-03-04', 'lastUpdatePostDateStruct': {'date': '2016-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non- compartment pharmacokinetic parameters', 'timeFrame': '1200 minutes'}, {'measure': 'Compartment pharmacokinetic parameters', 'timeFrame': '1200 minutes'}, {'measure': 'BIS', 'timeFrame': '1200 minutes'}, {'measure': 'SBP', 'timeFrame': '1200 minutes'}, {'measure': 'E0', 'timeFrame': '1200 minutes'}, {'measure': 'Emax', 'timeFrame': '1200 minutes'}, {'measure': 'Ce50', 'timeFrame': '1200 minutes'}, {'measure': 'ke0', 'timeFrame': '1200 minutes'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analysis PKPD of Freefol-MCT and to investigate relationship between the concentration of Freefol-MCT and the index which signaly analyzes those: EEG, EEG approximate entropy, systolic BP, saturation wave form and invasive BP wave form.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Adults over 20years old', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults males/Females aged over 20years\n* Health screening examination within 60 days of the start (Interview, vital signs , 12-lead ECG, blood tests, urinalysis) .\n* The applicant who agreed in writing by told an explanation enough about the characteristics of the study drug, the purpose of the test and the details.\n\nExclusion Criteria:\n\n* Subjects with clinically significant disease or history such as Liver, kidney, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous psychiatric, blood tumor system and cardiovascular. (In particular, bronchial asthma, severe hepatic, renal failure, severe blood disorders, severe myasthenia gravis, cardiac dysfunction, peptic ulcer, etc.)\n* Who had acute disease or organ dysfunction within four weeks of the start of the test.\n* Who had significant hematologic disorders or donate whole blood within two months of the start of the test.\n* Significant neuropsychiatric or more.\n* Continued drug abuse.\n* Who has a history of drug and other hypersensitivity reactions.\n* Positive at Type B / C hepatitis , syphilis tests (VDRL), if in AIDS antibody test\n* Who took other clinical medicine within two months of the start of the test.\n* Who smokes or drinks within two weeks after dosing.\n* Who takes drugs regularly other than the mineral claim or vitamin. However, it depends on judgment of the researchers.'}, 'identificationModule': {'nctId': 'NCT02384720', 'briefTitle': 'Study of Freefol-MCT PKPD in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewon Pharmaceutical Co., Ltd.'}, 'orgStudyIdInfo': {'id': 'Freefol_PKPD_2013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Gender: 10 Males, 10 Females', 'interventionNames': ['Other: Age: 20-40years']}, {'label': 'B', 'description': 'Gender: 10 Males, 10 Females', 'interventionNames': ['Other: Age: 41-64years']}, {'label': 'C', 'description': 'Gender: 10 Males, 10 Females', 'interventionNames': ['Other: Age: ≥65years']}], 'interventions': [{'name': 'Age: 20-40years', 'type': 'OTHER', 'armGroupLabels': ['A']}, {'name': 'Age: 41-64years', 'type': 'OTHER', 'armGroupLabels': ['B']}, {'name': 'Age: ≥65years', 'type': 'OTHER', 'armGroupLabels': ['C']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}