Pharmacokinetic Interactions in Combination Treatment of Valproic Acid and Ertapenem in Normal Subjects
NCT ID: NCT01073059
Last Updated: 2010-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2009-08-31
Brief Summary
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* This trial is performed to evaluate safety of the combination treatment compare with single treatment
* The investigators carry this trial out to study mechanism of combination treatment
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Valproic acid
Valproic acid and Ertapenem
Interventions
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Valproic acid and Ertapenem
Eligibility Criteria
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Inclusion Criteria
* Subjects who have a weight more then 50kg and a condition ± 20% range of ideal weight
Exclusion Criteria
* 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
* 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
* Subjects with known allergy, hypersensitivity (anaphylaxis-type reaction; especially penicillin antibiotics)
* Subjects with a history of drug abuse
* Subjects who received certain medication (include oriental medicine) within the past 3 weeks or certain OTC-drug within 1 week
* 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
* Subjects who are chronic drinkers
19 Years
50 Years
MALE
Yes
Sponsors
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Chonbuk National University
OTHER
Responsible Party
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Chonbuk National University Hospital
Principal Investigators
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Chang-Seop Lee, MD/Prof.
Role: PRINCIPAL_INVESTIGATOR
Chonbuk National University Hospital
Locations
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Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Countries
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Other Identifiers
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CUH_2009_VPA
Identifier Type: -
Identifier Source: org_study_id