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Completed

NCT Number: NCT01073059

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

* 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

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Key information

Conditions

Healthy

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chonbuk National University Hospital

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valproic acid and Ertapenem

Drug

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Chonbuk National University

Other

Registry information

Official study 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

Important dates

Study start
2009
First posted
Feb 23, 2010
Registry last updated
Dec 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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