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Completed

NCT Number: NCT02699658

Population Pharmacokinetics and Pharmacodynamics Modeling to Optimize Dosage Regimen of Levofloxacin

Levofloxacin, a fluoroquinolone antibiotic, is the optical S-(-) isomer of ofloxacin with a broad spectrum of activity. In common with other fluoroquinolones, the main pharmacokinetic/pharmacodynamic (PK/PD) index that correlates with its therapeutic efficacy is the area under the plasma time-concentration curve/the minimum inhibitory concentration ratios.

The aims of the study were to:

1. reveal the population pharmacokinetics, and 2. assess the efficacy of various dosage regimens in achieving the probability of target attainment (PTA) and the cumulative fraction of response (CFR) of levofloxacin when oral levofloxacin was prescribed as the switching therapy after intravenous levofloxacin treatment.

The study was conducted in 45 healthy volunteers. Each subject received one 500 mg tablet of levofloxacin, after which PK studies were carried out, using a Monte Carlo simulation to determine the PTA. By referral to the EUCAST MIC distributions database, the dosage regimens were predicted to achieve CFR greater than or equal to 90%.

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Key information

Conditions

Healthy Volunteers

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion:

  • normal hematologic
  • normal hepatic
  • normal renal functions
  • non-smoking
  • non-alcoholic
  • non-obese

Exclusion:

  • pregnant or lactating women
  • any chronic medications

Treatment and study plan

Levofloxacin

Drug

Primary outcomes

  1. concentration of levofloxacin in plasma

    Time frame: up to 2 week after blood collection

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 4, 2016
Registry last updated
Mar 4, 2016

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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