Clinical trial NCT01073059: Pharmacokinetic Interactions in Combination Treatment of Valproic Acid and Ertapenem in Normal Subjects
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: valproic acid
ertapenem
Lead sponsor: Chonbuk National University
Sponsor class: OTHER
First posted: 2010-02-23
Enrollment: 10
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: Chang-Seop Lee, MD/Prof.
role: PRINCIPAL_INVESTIGATOR
References: