Evidence map›Paper›PMID 11352443›Full record

Trial reportClinical pharmacokinetics2001

Effects of iron supplements on the oral bioavailability of moxifloxacin, a novel 8-methoxyfluoroquinolone, in humans.

H Stass, D Kubitza

Abstract readClinical TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Review
  10. Review
  11. Gender analysis of moxifloxacin clinical trials.Journal of women's health (2002) · 2014
    Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors at 1 institution in 1 country.

H StassPharma Research Centre, Institute of Clinical Pharmacology, Bayer AG, Wuppertal, Germany. Heino.Stass.hs@bayer-ag.de
D Kubitza
Bayer (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the effect of concomitant iron administration on the pharmacokinetics and tolerability of moxifloxacin.

designThis was a single-centre, nonblinded, randomised, 2-way crossover study in healthy male volunteers.

participants12 healthy males (age 19 to 41 years) were enrolled in the study.

methodsThe plasma and urinary pharmacokinetics of moxifloxacin were investigated after single oral doses of moxifloxacin 400mg given either alone or together with ferrous sulfate (Eryfer 100 equivalent to 100mg of Fe2+) administered concomitantly and again after 24 hours. There was a 1-week washout phase between the treatments. The plasma and urinary pharmacokinetics of moxifloxacin were characterised over the 72 hours after drug administration.

resultsThe treatments were well tolerated. The concomitant administration of Eryfer reduced the bioavailability of moxifloxacin [geometric mean area under the plasma concentration-time curve 20.7 versus 34.0 mg/L x h; relative bioavailability 61%, 90% confidence interval (CI) 54 to 69%] and slowed down the absorption rate (median time to maximum concentration 2.79 versus 1.0 hours), with a reduction in the mean maximum concentration (Cmax) [geometric mean Cmax 1.17 and 2.86 mg/L; estimated true ratio of Cmax 41%, 90% CI 34 to 49%].

conclusionsConcomitant ingestion of iron supplements significantly reduces the bioavailability of moxifloxacin. This is compatible with a reduction in solubilisation due to chelation with polyvalent cations, a common finding for quinolones. Because of the long half-life of moxifloxacin, staggered administration of moxifloxacin and potential cationic interactants should be considered to avoid a loss of therapeutic efficacy caused by subtherapeutic plasma concentrations of the quinolone.

Indexed as

Aza CompoundsFluoroquinolonesQuinolinesAdministration, OralAdultAnalysis of VarianceAnti-Infective AgentsArea Under CurveBiological AvailabilityCross-Over StudiesDietary SupplementsDrug InteractionsFerrous CompoundsHalf-LifeHumansIntestinal AbsorptionAnti-Infective AgentsAza CompoundsFerrous Compoundsferrous sulfateFluoroquinolonesMoxifloxacinQuinolines

Identifiers

PMID11352443
OpenAlexW2077507092

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.