Healthy
Conditions
Keywords
valproic acid, ertapenem
Brief summary
* 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
Interventions
DRUGValproic acid and Ertapenem
Sponsors
Chonbuk National University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed