Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-29 @ 12:00 PM
Study NCT ID:
NCT01230268
Status:
COMPLETED
Last Update Posted:
2010-12-14
First Post:
2010-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Mulberry Fruit Extract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-13', 'studyFirstSubmitDate': '2010-10-27', 'studyFirstSubmitQcDate': '2010-10-28', 'lastUpdatePostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax - Maximum Observed Concentration - C3G in Plasma', 'timeFrame': 'Blood samples collected over 6 hours'}, {'measure': 'AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - C3G in Plasma', 'timeFrame': 'Blood samples collected over 6 hours'}, {'measure': 'Antioxidative markers', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events', 'timeFrame': 'for 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['C3G', 'Oxidative stress', 'Antioxidant', 'Mulberry'], 'conditions': ['Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma concentration of C3G and the antioxidative markers such as total antioxidative capacity and attack of free oxygen radical will be measured.\n\nAdditional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg Mulberry fruit extract.\n\nThis study, as an exploratory trial, does not required statistical hypothesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight \\>55 kg for male, \\>45 kg for female (within 80-120% of Ideal body weight)\n* Give written informed consent and voluntarily decide participation\n\nExclusion Criteria:\n\n* Acute or chronic disease symptom on screening\n* Existing active and clinically significant disease involving more than one organ system\n* Known allergy to Mulberry or other berries\n* Positive drug or alcohol screening\n* Smokers of 10 or more cigarettes per day\n* Participation in a clinical trial during last 2 month prior to the start of the study\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01230268', 'acronym': 'C3G', 'briefTitle': 'A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Mulberry Fruit Extract', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'officialTitle': 'A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Mulberry Fruit Extract', 'orgStudyIdInfo': {'id': 'CPT2010-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mulberry fruit extract', 'description': 'Daily 1000 mg oral Mulberry fruit extract is given to each subject for 2 weeks from Day2 after measuring antioxidative marker without intervention on Day1.', 'interventionNames': ['Other: Mulberry fruit extract']}], 'interventions': [{'name': 'Mulberry fruit extract', 'type': 'OTHER', 'description': '1000 mg oral daily dose for 2 weeks', 'armGroupLabels': ['Mulberry fruit extract']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St.Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Dong-Seok Yim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seoul St. Mary's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Rural Development Administration, Korea', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Dong-Seok Yim', 'oldOrganization': "Seoul St. Mary's Hospital"}}}}