Pharmacokinetic Interactions in Combination Treatment of Valproic Acid and Ertapenem in Normal Subjects
Overview
– 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
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Health Services Research
- Masking: None (Open Label)
Interventions
- Drug: Valproic acid and Ertapenem
Arms, Groups and Cohorts
- Experimental: Valproic acid
Clinical Trial Outcome Measures
Primary Measures
- Maximum Plasma Concentration at Steady State (Cmax ss) in Valproic acid single treatment
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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
- Time Frame: serial pharmacokinetic plasma concentrations were drawn at 144, 145, 146, 147, 148, 149, 150, 152, and 156 hours according to protocol
Participating in This Clinical Trial
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
Gender Eligibility: Male
Minimum Age: 19 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Chonbuk National University
- Provider of Information About this Clinical Study
- Study Director, Chang-Seop Lee, Chonbuk National University Hospital
- Overall Official(s)
- Chang-Seop Lee, MD/Prof., Principal Investigator, Chonbuk National University Hospital
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