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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%.
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
Prince of Songkla University
Published on BioPortfolio: 2016-03-07T02:59:20-0500
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Persons with no known significant health problems who are recruited to participate in research to test a new drug, device, or intervention as controls for a patient group. (from http://clinicalcenter.nih.gov/recruit/volunteers.html, accessed 2/14/2013)
Hospital or other institutional ethics committees established to consider the ethical dimensions of patient care. Distinguish from ETHICS COMMITTEES, RESEARCH, which are established to monitor the welfare of patients or healthy volunteers participating in research studies.
Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.
The L-isomer of Ofloxacin.
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