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

This study has been completed.
Sponsor:
Information provided by:
Chonbuk National University
ClinicalTrials.gov Identifier:
NCT01073059
First received: February 19, 2010
Last updated: December 7, 2010
Last verified: February 2010
  Purpose
  • 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

Condition Intervention Phase
Healthy
Drug: Valproic acid and Ertapenem
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by Chonbuk National University:

Primary Outcome 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: August 2009
Arms Assigned Interventions
Experimental: Valproic acid Drug: Valproic acid and Ertapenem

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073059

Locations
Korea, Republic of
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 561-712
Sponsors and Collaborators
Chonbuk National University
Investigators
Principal Investigator: Chang-Seop Lee, MD/Prof. Chonbuk National University Hospital
  More Information

No publications provided

Responsible Party: Study Director, Chang-Seop Lee, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01073059     History of Changes
Other Study ID Numbers: CUH_2009_VPA
Study First Received: February 19, 2010
Last Updated: December 7, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chonbuk National University:
valproic acid
ertapenem

Additional relevant MeSH terms:
Ertapenem
Valproic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014