Healthy Volunteers Clinical Trial
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%.
n/a
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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