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

Condition(s) targeted: Healthy

Intervention: Valproic acid and Ertapenem (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Chonbuk National University

Official(s) and/or principal investigator(s):
Chang-Seop Lee, MD/Prof., Principal Investigator, Affiliation: Chonbuk National University Hospital

- 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: 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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome:

Maximum Plasma Concentration at Steady State (Cmax ss) in Valproic acid single treatment

Maximum Plasma Concentration at Steady State (Cmax ss) in Valproic acid and Ertapenem combination treatment

Area Under the Concentration Versus Time Curve in Valproic acid single treatment

Area Under the Concentration Versus Time Curve in Valproic acid and Ertapenem combination treatment

Minimum age: 19 Years. Maximum age: 50 Years. Gender(s): Male.

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

Chonbuk National University Hospital, Jeonju, Jeollabuk-do 561-712, Korea, Republic of

Starting date: August 2009
Last updated: December 7, 2010