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

Overview

– 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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)

Interventions

  • Drug: Valproic acid and Ertapenem

Arms, Groups and Cohorts

  • Experimental: Valproic acid

Clinical Trial Outcome Measures

Primary 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 19 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Chonbuk National University
  • Provider of Information About this Clinical Study
    • Study Director, Chang-Seop Lee, Chonbuk National University Hospital
  • Overall Official(s)
    • Chang-Seop Lee, MD/Prof., Principal Investigator, Chonbuk National University Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.