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2015 ; 59
(3
): 1446-54
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Pharmacokinetics and pharmacodynamics of multiple-dose intravenous nemonoxacin in
healthy Chinese volunteers
#MMPMID25534726
Antimicrob Agents Chemother
2015[Mar]; 59
(3
): 1446-54
PMID25534726
show ga
This study evaluated the safety and pharmacokinetic/pharmacodynamic profiles of
nemonoxacin in healthy Chinese volunteers following multiple-dose intravenous
infusion once daily for 10 consecutive days. The study was composed of two
stages. In the open-label stage, 500 mg or 750 mg of nemonoxacin (n = 12 each)
was administered at an infusion rate of 5.56 mg/min. In the second stage, with a
randomized double-blind placebo-controlled design, 500, 650, or 750 mg of
nemonoxacin (n = 16 in each cohort; 12 subjects received the drug and the other 4
subjects received the placebo) was given at an infusion rate of 4.17 mg/min. The
results showed that, in the first stage, the maximal nemonoxacin concentrations
(mean ± SD) at steady state (Cmax_ss) were 9.60 ± 1.84 and 11.04 ± 2.18 ?g/ml in
the 500-mg and 750-mg cohorts, respectively; the areas under the
concentration-time curve at steady state (AUC0-24_ss) were 44.03 ± 8.62 and 65.82
± 10.78 ?g · h/ml in the 500-mg and 750-mg cohorts, respectively. In the second
stage, the nemonoxacin Cmax_ss values were 7.13 ± 1.47, 8.17 ± 1.76, and 9.96 ±
2.23 ?g/ml in the 500-mg, 650-mg, and 750-mg cohorts, respectively; the
AUC0-24_ss values were 40.46 ± 9.52, 54.17 ± 12.10, and 71.34 ± 17.79 ?g · h/ml
in the 500-mg, 650-mg, and 750-mg cohorts, respectively. No accumulation was
found after the 10-day infusion with any regimen. The drug was well tolerated. A
Monte Carlo simulation indicated that the cumulative fraction of response of any
dosing regimen was nearly 100% against Streptococcus pneumoniae. The probability
of target attainment of nemonoxacin therapy was >98% when the MIC of nemonoxacin
against S. pneumoniae was ?1 mg/liter. It is suggested that all of the studied
intravenous nemonoxacin dosing regimens should have favorable clinical and
microbiological efficacies in future clinical studies. (This study has been
registered at ClinicalTrials.gov under registration no. NCT01944774.).