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Antimicrobial Agents and Chemotherapy, October 2000, p. 2600-2603, Vol. 44, No. 10
Department of Chest and Infectious Diseases,
Chest Hospital Heckeshorn,1 and
Department of Medical Physics, Benjamin Franklin
Hospital,2 Free University of Berlin, and
Institute of Clinical Chemistry and
Pathobiochemistry,3 Berlin, Germany
Received 18 November 1999/Returned for modification 18 March
2000/Accepted 15 June 2000
In an open, randomized, six-period crossover study, the
pharmacokinetics of ciprofloxacin, gatifloxacin, grepafloxacin,
levofloxacin, moxifloxacin, and trovafloxacin were compared after a
single oral dose in 12 healthy volunteers (6 men and 6 women). The
volunteers received 250 mg of ciprofloxacin, 400 mg of gatifloxacin,
600 mg of grepafloxacin, 500 mg of levofloxacin, 400 mg of
moxifloxacin, and 200 mg of trovafloxacin. The concentrations of the
six fluoroquinolones in serum and urine were measured by a validated
high-performance liquid chromatography method. Blood and urine samples
were collected before and at different time points up to 48 h
after medication. Levofloxacin had the highest peak concentration
(Cmax, in micrograms per milliliter) (6.21 ± 1.34), followed by moxifloxacin (4.34 ± 1.61) and gatifloxacin
(3.42 ± 0.74). Elimination half-lives ranged from 12.12 ± 3.93 h (grepafloxacin) to 5.37 ± 0.82 h
(ciprofloxacin). The total areas under the curve (AUCtot,
in microgram-hours per milliliter) for levofloxacin (44.8 ± 4.4),
moxifloxacin (39.3 ± 5.35), and gatifloxacin (30 ± 3.8)
were significantly higher than that for ciprofloxacin (5.75 ± 1.25). Calculated from a normalized dose of 200 mg, the highest
Cmaxs (in micrograms per milliliter) were
observed for levofloxacin (2.48 ± 0.53), followed by moxifloxacin (2.17 ± 0.81) and trovafloxacin (2.09 ± 0.58). The highest
AUCtot (in microgram-hours per milliliter) for a 200-mg
dose were observed for moxifloxacin (19.7 ± 2.67) and
trovafloxacin (19.5 ± 3.1); the lowest was observed for
ciprofloxacin (4.6 ± 1.0). No serious adverse event was observed
during the study period. The five recently developed fluoroquinolones
(gatifloxacin, grepafloxacin, levofloxacin, moxifloxacin, and
trovafloxacin) showed greater bioavailability, longer half-lives, and
higher Cmaxs than ciprofloxacin.
Fluoroquinolones are widely used
alternatives to We therefore evaluated and compared the pharmacokinetics of six
fluoroquinolones after a single oral dose in the same volunteers.
(This work was presented in part at the 39th Interscience Conference on
Antimicrobial Agents and Chemotherapy, San Francisco, Calif., 26 to 29 September 1999 [I. Keller et al., Abstr. 39th Intersci. Conf.
Antimicrob. Agents Chemother., abstr. 1190, 1999].)
Volunteers.
Six male and six female young healthy Caucasians
between 21 and 35 years old (mean, 28.4 ± 4.3 years) and with an
average weight of 67.4 ± 10.6 kg and an average body surface of
1.81 ± 0.16 m2 participated in the study. All had
normal renal and hepatic functions; the mean creatinine clearance was
113 ± 19.5 ml/min/1.73 m2. The volunteers were
included in the study protocol after normal findings from physical
examination, electrocardiogram (ECG), and laboratory tests (including
hematological and biochemical parameters, hepatitis and human
immunodeficiency virus serological tests, tests for drug abuse,
urinalysis, and pregnancy test). Exclusion criteria were regular use of
medications; abuse of alcoholic beverages; symptoms of significant
illness within 3 months before the study period; history of
gastrointestinal, liver, or kidney disease potentially interfering with
absorption, metabolism, or excretion of drugs; history of central
nervous system (CNS) disorders; allergy or hypersensitivity to the
study drugs; blood donation of more than 500 ml during the previous 3 months; participation in a clinical trial within 3 months before the
study period; and pregnancy. Written informed consent was obtained from
all volunteers prior to inclusion in the study protocol. The study was
approved by the Ethics Committee of Benjamin Franklin Hospital, Free
University of Berlin, Berlin, Germany.
Study design.
The study was performed in an open,
randomized, six-period crossover design. Each volunteer received each
drug once, followed by a 2-week washout period. The tablets were
administered with 240 ml of water after an overnight fasting period of
12 h and contained the following dosages: 250 mg of
ciprofloxacin (Bayer AG, Leverkusen, Germany), 400 mg of
gatifloxacin (Grünenthal GmbH, Aachen, Germany), 600 mg of
grepafloxacin (Glaxo Wellcome, Hamburg, Germany), 500 mg of
levofloxacin (Hoechst Marion Roussel GmbH, Bad Soden am Taunus,
Germany), 400 mg of moxifloxacin (Bayer AG), and 200 mg of
trovafloxacin (Pfizer GmbH, Karlsruhe, Germany). These dosages were
based on the most frequent and recommended oral dosages for outpatient treatment.
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Copyright © 2000, American Society for Microbiology. All rights reserved.
Comparative Pharmacokinetics of Ciprofloxacin,
Gatifloxacin, Grepafloxacin, Levofloxacin, Trovafloxacin, and
Moxifloxacin after Single Oral Administration in Healthy
Volunteers
ABSTRACT
Top
Abstract
Introduction
Materials and Methods
Results
Discussion
References
INTRODUCTION
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Abstract
Introduction
Materials and Methods
Results
Discussion
References
-lactam agents in the treatment of many bacterial
infections. Their antimicrobial activity results from a selective
antagonism between host DNA and bacterial DNA without interfering with
eucaryotic topoisomerases. The early fluoroquinolones, from the early
1960s, had a limited spectrum of antibacterial activity, mainly against
gram-negative pathogens. Further observations of structure-related
increases in activity, changes in pharmacokinetic characteristics, and
reduced toxicity were followed by numerous chemical modifications of
the quinolone molecule. The resulting new fluoroquinolone antimicrobial agents have enhanced activity against gram-positive organisms and
anaerobes (1, 2) and improved pharmacokinetic parameters in
comparison to previous derivatives. However, only reports on single-drug kinetics have been published so far, and there have been no
direct comparisons between the new drugs and the standard drug,
ciprofloxacin (1-3).
MATERIALS AND METHODS
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Abstract
Introduction
Materials and Methods
Results
Discussion
References
ECG. ECG for controlling the Q-T interval was done before and 12 h after each medication.
Side effects. Side effects were noted by spontaneous reporting and by questioning during examinations 12, 24, and 48 h after medication.
Sampling.
Blood samples were collected before and 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 h after medication through an
indwelling cannula. Five milliliters of blood was taken for
high-performance liquid chromatography (HPLC) analyses of all
fluoroquinolones. After blood collection to obtain serum, the samples
were stored at room temperature for about 30 min. All samples were
centrifuged for 10 min at 1,000 × g and 21°C to separate
the serum, which was then shock frozen at 
20°C.
20°C. All samples (serum and urine) were protected against light
during processing and storage.
HPLC. Concentrations of ciprofloxacin, gatifloxacin, grepafloxacin, levofloxacin, moxifloxacin, and trovafloxacin in serum and urine were determined by a validated HPLC method involving protein precipitation. For the analysis of gatifloxacin, grepafloxacin, and moxifloxacin, trovafloxacin was added as an internal standard. The extract was then chromatographed and quantified by fluorimetric detection. Urine samples were diluted only for the mobile phase. Details of the analysis of ciprofloxacin, levofloxacin, and trovafloxacin have been described previously (4, 5, 7). HPLC measurements for gatifloxacin, moxifloxacin, and grepafloxacin were similar to those for ciprofloxacin. Each method was validated. The detection limits were between 0.02 and 0.06 mg/liter in serum and 0.99 and 9.0 mg/liter in urine. The limits of quantitation ranged between 0.03 and 0.11 mg/liter in serum and 1.5 and 18.1 mg/liter in urine. Levels of precision within series were between 1.0 to 2.2% and 5.4 to 7.9% for serum and 1.1 to 2.0% and 2.2 to 4.8% for urine. Levels of precision between series ranged from 4.1 to 5.2% and 1.6 to 12.8% in serum and from 1.7 to 2.9% and 5.0 to 11.2% in urine.
Pharmacokinetic analysis. The serum and urine data were analyzed with an open two-compartment model (peak concentration [Cmax], time to peak concentration [Tmax], time between drug administration and beginning of absorption [Tlag], and terminal half-life) chosen according to the Schwarz criterion (12, 13, 15). All other parameters were analyzed noncompartmentally (total areas under the curve [AUCtot], volume of distribution at steady state [Vss], mean residence time [MRT], and urinary recovery). The dose-dependent parameters (AUCtot and Cmax) were based on a dose per 70 kg of body weight. The main pharmacokinetic parameters (Cmax and AUCtot) of the different fluoroquinolones were additionally calculated for an average dose of 200 mg per 70 kg.
The calculations were elaborated using REVOL (14) for nonlinear regression analysis and Microsoft Excel for pharmacokinetic analysis.Statistical analysis. All fluoroquinolones were compared by variance analysis with the Student-Newman-Keuls procedure for multiple comparisons of sample means. P values of <0.05 were considered significant; P values of <0.01 were considered highly significant.
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RESULTS |
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Abstract
Introduction
Materials and Methods
Results
Discussion
References
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Pharmacokinetics.
The pharmacokinetic data for all six
fluoroquinolones, determined by HPLC, are shown in Fig.
1 and listed in Table
1. Levofloxacin showed the highest
Cmax, 6.1 ± 1.3 µg/ml/70 kg, at 0.8 ± 0.4 h (Tmax) after medication, followed
by moxifloxacin (Cmax, 4.3 ± 1.6 µg/ml;
Tmax, 1.0 ± 0.7 h) and gatifloxacin
(Cmax, 3.4 ± 0.7 µg/ml;
Tmax, 1.5 ± 0.6 h). The lowest
concentration in serum was observed for ciprofloxacin, 1.5 ± 0.4 µg/ml, after 0.8 ± 0.3 h. The AUCtot for
ciprofloxacin (5.8 ± 1.2 µg · h/ml) was also
significantly lower than those for the newer fluoroquinolones
(P < 0.01). The longest half-life was observed for
grepafloxacin (12.1 ± 3.9 h), followed by trovafloxacin
(10.3 ± 3.4 h). The Tlag ranged
between 0.12 ± 0.16 h (trovafloxacin) and 0.34 ± 0.06 h (grepafloxacin). Total urinary recovery, defined as the
percentage of the administered dose over 48 h, was highest for
gatifloxacin (77% ± 6%) and levofloxacin (76% ± 12%) and lowest
for trovafloxacin (9.3% ± 2.5%).
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Side effects. The overall tolerance of the six fluoroquinolones was good. Most side effects were registered with trovafloxacin. Nine volunteers (six women and three men) complained of mild to moderate CNS effects (dizziness, headache, and lack of concentration), three complained of gastrointestinal side effects (nausea and flatulence), and one complained of dry nasal mucosa. The main side effects with the other fluoroquinolones (n = 9) were headache and gastrointestinal disturbances (flatulence and diarrhea). The side effects were mild to moderate, in no case severe, and no volunteer had to be withdrawn from the study. No changes in ECG (Q-T interval), clinical examination, or vital and laboratory parameters (clinical chemistry, hematology, and urinalysis) were observed.
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DISCUSSION |
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Abstract
Introduction
Materials and Methods
Results
Discussion
References
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Most of our pharmacokinetic results for all six fluoroquinolones were in reasonable concurrence with published studies (6-11, 14, 16-18), except in the following parameters. For ciprofloxacin we found a higher AUCtot (5.75 ± 1.25 versus 4.23 ± 1.1) (6), and for gatifloxacin we found a shorter half-life (6.52 ± 0.87 versus 8.6 ± 1.4 h) (14). In our study, grepafloxacin had a higher Cmax (1.98 ± 0.52 versus 1.41 ± 0.28 µg/ml) than was described earlier (9, 10). Our findings for moxifloxacin were similar to those of Wise et al. (18) but differed from those of Stass et al. (16). For trovafloxacin, we noted a remarkably lower AUCtot (19.5 ± 3.1 versus 30.4 ± 8.1 µg/ml) (11, 17); also, the Tmax was significantly shorter (0.95 ± 0.61 versus 2.3 ± 1.0 h) (17).
Compared to data for ciprofloxacin as a standard fluoroquinolone, the peak Cmaxs of gatifloxacin, levofloxacin, and moxifloxacin were significantly higher (P < 0.01) and the AUCtot for all newer fluoroquinolones were significantly higher (P < 0.01).
Based on an average dose of 200 mg, levofloxacin had the highest Cmax (2.48 ± 0.534 µg/ml), followed by moxifloxacin (2.17 ± 0.805 µg/ml) and trovafloxacin (2.09 ± 0.58 µg/ml), but the highest AUCtot were found for moxifloxacin (19.7 ± 2.67 µg · h/ml/70 kg) and trovafloxacin (19.5 ± 3.1 µg · h/ml/70 kg). The Cmaxs of levofloxacin, moxifloxacin, and trovafloxacin were significantly higher than that of ciprofloxacin (P < 0.01), and the AUCtot for all newer fluoroquinolones were significantly higher (P < 0.01).
As is well known, longer elimination half-lives afford once-daily dosing of trovafloxacin, moxifloxacin, grepafloxacin, and gatifloxacin while maintaining levels in serum above the MICs for dominant pathogens. The urinary recovery of the unchanged drug (percentage of the administered dose) ranged between 9.27% ± 2.47% for trovafloxacin and 76.9% ± 5.6% for gatifloxacin, depending on the different elimination routes (renal versus hepatic routes).
The overall tolerance of the fluoroquinolones administered in our study was good. Most of the adverse effects were observed for trovafloxacin (mainly affecting the CNS). No volunteer had to be withdrawn from the study. No changes in vital signs, clinical chemistry, hematology, or urinalysis were observed in relation to the study medication. Also, no changes in Q-T interval or other changes in ECG were noted after a single oral administration of each of the six fluoroquinolones.
In conclusion, our results demonstrate that the newer fluoroquinolones gatifloxacin, moxifloxacin, grepafloxacin, trovafloxacin, and levofloxacin offer more favorable pharmacokinetic parameters (significantly higher AUCtot and Cmaxs and longer elimination half-lives) than the standard fluoroquinolone ciprofloxacin.
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ACKNOWLEDGMENTS |
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The excellent technical assistance of H. Hartwig, E. Borner, M. Rau, and G. Schreiber is gratefully acknowledged.
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FOOTNOTES |
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* Corresponding author. Mailing address: Department of Chest and Infectious Diseases, Chest Hospital Heckeshorn, Zum Heckeshorn 33, D-14109 Berlin, Germany. Phone: 49 (0)30 8002 2222. Fax: 49 (0)30 8002 2623. E-mail: haloheck{at}zedat.fu-berlin.de.
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References
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Antimicrobial Agents and Chemotherapy, October 2000, p. 2600-2603, Vol. 44, No. 10
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Copyright © 2000, American Society for Microbiology. All rights reserved.
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