Pharmacokinetic Interactions in Combination Treatment of Valproic Acid and Ertapenem in Normal Subjects

Study Overview
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Brief Summary
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This trial is conducted to assess pharmacokinetic characteristics of valproic acid when valproic acid single treatment and valproic acid & ertapenem combination treatment 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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Valproic acid and Ertapenem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are healthy volunteers, men 19 50 years Subjects who have a weight more then 50kg and a condition ± 20% range of ideal weight Exclusion Criteria: Subjects with evidence of clinically significant hepatic, pancreatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric or cardiovascular disease 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valproic acid<br> | Drug: Valproic acid and Ertapenem<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration at Steady State (Cmax ss) in Valproic acid single treatment |  | serial pharmacokinetic plasma concentrations were drawn at 72, 73, 74, 75, 76, 77, 78, 80, and 84 hours according to protocol | 
| Maximum Plasma Concentration at Steady State (Cmax ss) in Valproic acid and Ertapenem combination treatment |  | serial pharmacokinetic plasma concentrations were drawn at 144, 145, 146, 147, 148, 149, 150, 152, and 156 hours according to protocol | 
| Area Under the Concentration Versus Time Curve in Valproic acid single treatment |  | serial pharmacokinetic plasma concentrations were drawn at 72, 73, 74, 75, 76, 77, 78, 80, and 84 hours according to protocol | 
| Area Under the Concentration Versus Time Curve in Valproic acid and Ertapenem combination treatment |  | serial pharmacokinetic plasma concentrations were drawn at 144, 145, 146, 147, 148, 149, 150, 152, and 156 hours according to protocol | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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valproic acid, ertapenem