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Population Pharmacokinetics and Pharmacodynamics Modeling to Optimize Dosage Regimen of Levofloxacin

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ClinicalTrials.gov Identifier: NCT02699658
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Sutep Jaruratanasirikul, Prince of Songkla University

Brief Summary:

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%.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Levofloxacin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : October 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: levofloxacin in healthy Drug: Levofloxacin



Primary Outcome Measures :
  1. concentration of levofloxacin in plasma [ Time Frame: up to 2 week after blood collection ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

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

Exclusion:

  • pregnant or lactating women
  • any chronic medications

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): NCT02699658


Locations
Thailand
Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
Hat Yai, Songkla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University

Responsible Party: Sutep Jaruratanasirikul, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT02699658     History of Changes
Other Study ID Numbers: Levo-57-356141
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: February 2016

Keywords provided by Sutep Jaruratanasirikul, Prince of Songkla University:
levofloxacin
population pharmacokinetics
pharmacodynamics

Additional relevant MeSH terms:
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors