Skip to main content
Hauptrubriken
CME Facharzt-Training Webinare Zeitschriften Bücher e.Medpedia Podcast
Service
Jobbörse Info & Hilfe
Fachgebiete
Anästhesiologie Allgemeinmedizin Arbeitsmedizin Augenheilkunde Chirurgie Dermatologie Gynäkologie und Geburtshilfe HNO Innere Medizin Kardiologie Neurologie Onkologie und Hämatologie Orthopädie und Unfallchirurgie Pädiatrie Pathologie Psychiatrie Radiologie Rechtsmedizin Urologie Zahnmedizin
Themen
Klimawandel und Gesundheit Neues aus dem Markt COVID-19 Praxis und Beruf Seltene Erkrankungen GOÄ & EBM Panorama
Sammlungen
Kasuistiken Algorithmen & Infografiken Blickdiagnosen Arthropedia FlapFinder (für Dermatochirurgen) Videos Kongressberichterstattung Medizin für Apothekerinnen und Apotheker Für Ärztinnen und Ärzte in Weiterbildung Für Medizinstudierende
Erweiterte Suche
Anmelden
nach oben
Clinical Pharmacokinetics
Erschienen in: Clinical Pharmacokinetics 1/2001

01.12.2001 | Original Research Article

Effect of Food on the Pharmacokinetics of a Single Oral Dose of Moxifloxacin 400mg in Healthy Male Volunteers

verfasst von: Dr John Lettieri, Ramon Vargas, Vipin Agarwal, Patrick Liu

Erschienen in: Clinical Pharmacokinetics | Sonderheft 1/2001

Einloggen, um Zugang zu erhalten

Abstract

Objective

To investigate the effects of concomitant food intake on the pharmacokinetics of a single oral dose of moxifloxacin 400mg.

Design

This was a randomised 2-way nonblinded crossover study in healthy volunteers.

Participants

18 young, healthy, male volunteers were enrolled in the study, of whom 16 were considered evaluable for the pharmacokinetic analysis.

Methods

Moxifloxacin was given under 2 conditions separated by a 1-week washout period: fasted and fed (immediately after a standardised high fat breakfast). Concentrations of moxifloxacin in serum were determined by a validated high performance liquid chromatography procedure with fluorescence detection.

Outcome measures

Pharmacokinetic parameters such as maximum concentration (Cmax), time to reach Cmax (tmax), area under the concentration-time curve from zero to 48 hours (AUC48h), AUC from zero extrapolated to infinity (AUC∞) and elimination half-life (t1/2,z) were estimated using noncompartmental methods. The natural logarithms of AUC and Cmax were analysed using analysis of variance. Bioequivalence of the 2 treatments was determined at the 5% significance level with the two 1-sided tests procedure and limits of 80% and 125% for AUC and 70 to 143% for Cmax.

Results

The mean serum concentration versus time profiles were similar between the 2 treatments. The geometric mean AUC∞ values under fed and fasted conditions were almost identical, 37.7 versus 38.5 mg/L · h, respectively [90% confidence interval (CI) of the ratio of fed versus fasted based on geometric least-square means was 0.95, 1.00]. Geometric mean Cmax values were slightly reduced by food, 2.5 versus 2.8 mg/L, respectively (90% CI of fed versus fasted based on geometric least-square means was 0.78, 0.98). The absorption of moxifloxacin seems to be mildly delayed because of the effect of food; the median tmax values were 1.0 and 2.5 hours for fasted and fed conditions, respectively. The single oral dose of moxifloxacin 400mg was well tolerated when taken with and without food.

Conclusions

The criteria for bioequivalence with respect to Cmax and AUC∞ were met when moxifloxacin 400mg was given on an empty stomach or immediately after a high fat meal. Moxifloxacin may be given to patients with or without food.
Literatur
1.
Woodcock JM, Andrews JM, Boswell FJ, et al. In vitro activity of BAY 12-8039, a new fluoroquinolone. Antimicrob Agents Chemother 1997; 41: 101–6CrossRef
2.
Brueggemann AB, Kugler KC, Doern GV. In vitro activity of BAY 12-8039, a novel 8-methoxyquinolone, compared to activities of six fluoroquinolones against Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Antimicrob Agents Chemother 1997; 41: 1594–7CrossRef
3.
Felmingham D, Robbins MJ, Leakey A, et al. In vitro activity of Bay 12-8039 against bacterial respiratory tract pathogens, Mycoplasmas, and obligate anaerobic bacteria [abstract no. F8]. 36th Interscience Conference on Antimicrobial Agents and Chemotherapy; 1996 Sep 15–18; New Orleans, Louisiana: 101
4.
Georgopoulous A, Buxbaum A, Graninger W. Activity of Bay 12-8039 against 1154 clinical isolates of Streptococcus pneumoniae [abstract no. F5]. 36th Interscience Conference on Antimicrobial Agents and Chemotherapy; 1996 Sep 15/2-18; New Orleans, Louisiana: 100
5.
Ruckdeschel G, Dalhoff A. The in-vitro activity of moxifloxacin, against Legionella species and the effects of medium on susceptibility test results. J Antimicrob Chemother 1999; 43(Suppl. B): 25–9CrossRef
6.
Bebear CM, Renaudin H, Boudjadja A, et al. In vitro activity of BAY 12-8039, a new fluoroquinolone, against mycoplasmas. Antimicrob Agents Chemother 1998; 42: 703–4CrossRef
7.
Roblin PM, Hammerschlag MR. In vitro activity of a new 8-methoxyquinolone, BAY 12-8039, against Chlamydia pneumoniae. Antimicrob Agents Chemother 1998; 42(4): 951–2CrossRef
8.
Kubitza D, Stass HH, Wingender W, et al. Bay 12-8039, a new 8-methoxyquinolone: safety, tolerability and steady-state pharmacokinetics in healthy male volunteers [abstract no. F25]. 36th Interscience Conference on Antimicrobial Agents and Chemotherapy; 1996 Sep 15/2-18; New Orleans, Louisiana: 101
9.
Stass HH, Dalhoff A, Kubitza D, et al. Bay 12-8039, a new 8-methoxyquinolone: first pharmacokinetic results in healthy male volunteers [abstract no. F24]. 36th Interscience Conference on Antimicrobial Agents and Chemotherapy; 1996 Sep 15–18; New Orleans, Louisiana: 101
10.
Stass H, Kubitza D, Schühly U, et al. Pharmacokinetics, safety and tolerability of 800 mg BAY 12-8039 administered orally as a single dose [abstract no. P388]. 8th European Congress of Clinical Microbiology and Infectious Diseases; 1997 May 25–28; Lausanne, Switzerland. Clin Microbiol Infection 1997; 3 Suppl. 2: 87
11.
Stass H, Dalhoff A, Kubitza D, et al. Pharmacokinetics, safety, and tolerability of ascending single doses of moxifloxacin, a new 8-methoxy quinolone, administered to healthy subjects. Antimicrob Agents Chemother 1998; 42: 2060–5CrossRef
12.
Polk RE. Drug-drug interactions with Ciprofloxacin and other fluoroquinolones. Am J Med 1989; 87(Suppl. 5A): 76s–81CrossRef
13.
Ledergerber B, Bettex J-D, Joos B, et al. Effect of standard breakfast on drug absorption and multiple-dose pharmacokinetics of Ciprofloxacin. Antimicrob Agents Chemother 1985; 27(3): 350–2CrossRef
14.
Frost RW, Carlson JD, Dietz Jr AJ, et al. Ciprofloxacin pharmacokinetics after a standard or high-fat/high-calcium breakfast. J Clin Pharmacol 1989; 29(10): 953–5CrossRef
15.
Hoffken G, Lode H, Wiley R, et al. Pharmacokinetics and bioavailability of Ciprofloxacin and Ofloxacin: effect of food and antacid intake. Rev Infect Dis 1988; 10 Suppl. 1: S138–9
16.
Dudley MN, Marchbanks CR, Flor SC, et al. The effect of food or milk on the absorption kinetics of Ofloxacin. Eur J Clin Pharmacol 1991; 41: 569–71CrossRef
17.
Somogyi AA, Bochner F, Keal JA, et al. Effect of food on enoxacin absorption. Antimicrob Agents Chemother 1987; 31: 638–9CrossRef
18.
Lee LJ, Hafkin B, Lee ID, et al. Effects of food and sucralfate on a single oral dose of 500 milligrams of levofloxacin in healthy subjects. Antimicrob Agents Chemother 1997; 41: 2196–200CrossRef
19.
Stass HH, Dalhoff A, Kubitza D. BAY 12-8039: study on the food effects after oral administration of 200mg SD to healthy volunteers [abstract no. P386]. 8th European Congress of Clinical Microbiology and Infectious Diseases; 1997 May 25–28; Lausanne, Switzerland. Clin Microbiol Infection 1997; 3 Suppl. 2: 86
20.
Teng R, Dogolo LC, Willavize SA, et al. Oral bioavailability of trovafloxacin with and without food in healthy volunteers. J Antimicrob Chemother 1997; 39 Suppl. B: 87–92CrossRef
21.
Welling PG, Tse FL. The influence of food on the absorption of antimicrobial agents. J Antimicrob Chemother 1982; 9: 7–27CrossRef
22.
Stass H, Dalhoff A. Determination of BAY 12-8039, a new 8-methoxyquinolone, in human body fluids by high-performance liquid chromatography with fluorescence detection using on-column focusing. J Chromatogr B Biomed Sci Appl 1997; 702: 163–74CrossRef
23.
Gibaldi M, Perrier D. Pharmacokinetics. 2nd ed. New York: Marcel Dekker Inc., 1982: 409–16
24.
Food-effect bioavailability and bioequivalence studies. Draft Guidance for Industry. Bethesda (MD): US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research, Dec 1997
Metadaten
Titel
Effect of Food on the Pharmacokinetics of a Single Oral Dose of Moxifloxacin 400mg in Healthy Male Volunteers
verfasst von
Dr John Lettieri
Ramon Vargas
Vipin Agarwal
Patrick Liu
Publikationsdatum
01.12.2001
Verlag
Springer International Publishing
Erschienen in
Clinical Pharmacokinetics / Ausgabe Sonderheft 1/2001
Print ISSN: 0312-5963
Elektronische ISSN: 1179-1926
DOI
https://doi.org/10.2165/00003088-200140001-00003

Weitere Artikel der Sonderheft 1/2001

Clinical Pharmacokinetics 1/2001 Zur Ausgabe

Original Research Article

Pharmacokinetics, Safety and Tolerability of Moxifloxacin, a Novel 8-Methoxyfluoroquinolone, after Repeated Oral Administration

Original Research Article

Effect of Probenecid on the Kinetics of a Single Oral 400mg Dose of Moxifloxacin in Healthy Male Volunteers

Original Research Article

Effects of Sucralfate on the Oral Bioavailability of Moxifloxacin, a Novel 8-Methoxyfluoroquinolone, in Healthy Volunteers

Original Research Article

Effects of Dairy Products on the Oral Bioavailability of Moxifloxacin, a Novel 8-Methoxyfluoroquinolone, in Healthy Volunteers

Original Research Article

Effect of Calcium Supplements on the Oral Bioavailability of Moxifloxacin in Healthy Male Volunteers

Original Research Article

Evaluation of the Influence of Antacids and H2 Antagonists on the Absorption of Moxifloxacin after Oral Administration of a 400mg Dose to Healthy Volunteers