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

NCT01073059 | Completed Phase 1 DMC

• 1 other identifier: CUH_2009_VPA
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

valproic acid; ertapenem

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Valproic acid

EXPERIMENTAL

Drug: Valproic acid and Ertapenem

Interventions

Valproic acid and Ertapenem DRUG

Valproic acid

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 561-712, South Korea

Location

MeSH Terms

Interventions

Valproic Acid; Ertapenem

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Carbapenems; beta-Lactams; Lactams; Amides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Chang-Seop Lee, MD/Prof.

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 23, 2010
• Study Start: August 1, 2009
• Last Updated: December 8, 2010

Record last verified: 2010-02

Locations

KR (1)