Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-26 @ 8:54 PM
Study NCT ID:
NCT01073059
Status:
COMPLETED
Last Update Posted:
2010-12-08
First Post:
2010-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Interactions in Combination Treatment of Valproic Acid and Ertapenem in Normal Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-01-11', 'releaseDate': '2010-12-27'}, {'resetDate': '2011-03-08', 'releaseDate': '2011-02-14'}], 'estimatedResultsFirstSubmitDate': '2010-12-27'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D014635', 'term': 'Valproic Acid'}, {'id': 'D000077727', 'term': 'Ertapenem'}], 'ancestors': [{'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'lastUpdateSubmitDate': '2010-12-07', 'studyFirstSubmitDate': '2010-02-19', 'studyFirstSubmitQcDate': '2010-02-22', 'lastUpdatePostDateStruct': {'date': '2010-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration at Steady State (Cmax ss) in Valproic acid single treatment', 'timeFrame': 'serial pharmacokinetic plasma concentrations were drawn at 72, 73, 74, 75, 76, 77, 78, 80, and 84 hours according to protocol'}, {'measure': 'Maximum Plasma Concentration at Steady State (Cmax ss) in Valproic acid and Ertapenem combination treatment', 'timeFrame': 'serial pharmacokinetic plasma concentrations were drawn at 144, 145, 146, 147, 148, 149, 150, 152, and 156 hours according to protocol'}, {'measure': 'Area Under the Concentration Versus Time Curve in Valproic acid single treatment', 'timeFrame': 'serial pharmacokinetic plasma concentrations were drawn at 72, 73, 74, 75, 76, 77, 78, 80, and 84 hours according to protocol'}, {'measure': 'Area Under the Concentration Versus Time Curve in Valproic acid and Ertapenem combination treatment', 'timeFrame': 'serial pharmacokinetic plasma concentrations were drawn at 144, 145, 146, 147, 148, 149, 150, 152, and 156 hours according to protocol'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['valproic acid', 'ertapenem'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '* This trial is conducted to assess pharmacokinetic characteristics of valproic acid when valproic acid single treatment and valproic acid \\& ertapenem combination treatment\n* This trial is performed to evaluate safety of the combination treatment compare with single treatment\n* The investigators carry this trial out to study mechanism of combination treatment'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who are healthy volunteers, men 19\\~50 years\n* Subjects who have a weight more then 50kg and a condition ± 20% range of ideal weight\n\nExclusion Criteria:\n\n* Subjects with evidence of clinically significant hepatic, pancreatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric or cardiovascular disease\n* Subjects who have a GI disease (crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery\n* Subjects with uncontrolled hypotension (indicated by a sitting systolic blood pressure≤ 100 mmHg or diastolic blood pressure≤ 65 mmHg measured) and hypertension (indicated by a sitting systolic blood pressure≥ 150 mmHg or diastolic blood pressure≥ 95 mmHg measured) at vital sign measurement\n* Subjects with known allergy, hypersensitivity (anaphylaxis-type reaction; especially penicillin antibiotics)\n* Subjects with a history of drug abuse\n* Subjects who received certain medication (include oriental medicine) within the past 3 weeks or certain OTC-drug within 1 week\n* Subjects who participated in other clinical investigation within 2months prior to first administration Subjects who did whole blood donation (within 2months) or apheresis (within 1months) prior to first administration\n* Subjects who are chronic drinkers"}, 'identificationModule': {'nctId': 'NCT01073059', 'briefTitle': 'Pharmacokinetic Interactions in Combination Treatment of Valproic Acid and Ertapenem in Normal Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University'}, 'officialTitle': 'Open-label, Two-period, One Sequence, Multiple Dose, Crossover Study, A Study to Investigate Pharmacokinetic Interactions in Combination Treatment of Valproic Acid and Ertapenem in Normal Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'CUH_2009_VPA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Valproic acid', 'interventionNames': ['Drug: Valproic acid and Ertapenem']}], 'interventions': [{'name': 'Valproic acid and Ertapenem', 'type': 'DRUG', 'armGroupLabels': ['Valproic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '561-712', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}], 'overallOfficials': [{'name': 'Chang-Seop Lee, MD/Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonbuk National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Study Director, Chang-Seop Lee', 'oldOrganization': 'Chonbuk National University Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2010-12-27', 'type': 'RELEASE'}, {'date': '2011-01-11', 'type': 'RESET'}, {'date': '2011-02-14', 'type': 'RELEASE'}, {'date': '2011-03-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Chonbuk National University Hospital (Study Director, Chang-Seop Lee)'}}}}