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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01073059
First Posted: February 23, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chonbuk National University
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]
  • 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 ]
  • 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 ]
  • 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 ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 19, 2010
First Posted: February 23, 2010
Last Update Posted: October 12, 2017
Last Verified: February 2010

Keywords provided by Chonbuk National University:
valproic acid
ertapenem

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