Evidence map›Paper›PMID 11352440›Full record

Trial reportClinical pharmacokinetics2001

Effects of dairy products on the oral bioavailability of moxifloxacin, a novel 8-methoxyfluoroquinolone, in healthy volunteers.

H Stass, D Kubitza

Registry-linked trialAbstract 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. It is linked to trial NCT02563327 (TBTC Study 31 PK/PD), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
2.7field-weighted citation impact, top 10% 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.

NCT02563327 phase3completednot on this mapstarted 2016, after this paper: background citation

TBTC Study 31 PK/PD: Population Pharmacokinetic and Pharmacodynamic Study of Efficacy and Safety of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis in the Study 31 Treatment Trial: Intensive PK Sampling

TypeinterventionalSponsorCenters for Disease Control and PreventionRan2016 to 2021Enrolled2,516ConditionsTuberculosisArmsRifapentine, Moxifloxacin, Rifampin, Isoniazid, Pyrazinamide
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Treatment of Drug-Resistant Tuberculosis. An Official ATS/CDC/ERS/IDSA Clinical Practice Guideline.American journal of respiratory and critical care medicine · 2019
    Guideline
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. [Oral antibiotics: even in severe infections?]Innere Medizin (Heidelberg, Germany) · 2026
    Review
  9. Pharmacokinetics and safety of moxifloxacin in children with multidrug-resistant tuberculosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2015
    Article
  10. Gender analysis of moxifloxacin clinical trials.Journal of women's health (2002) · 2014
    Review
  11. Article
  12. Review
  13. Article
  14. 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 administration of dairy products on the pharmacokinetics and tolerability of moxifloxacin.

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

participants12 healthy men (aged 25 to 46 years) were enrolled in the study.

methodsThe plasma and urinary pharmacokinetics of moxifloxacin were investigated after single doses of moxifloxacin 400mg administered orally either under fasting conditions or immediately after 250g of yoghurt that was to be consumed within 15 minutes. There was a 1-week interval between the study periods.

resultsAdministration of moxifloxacin after yoghurt had no effect on the extent of absorption, as estimated by the area under the plasma concentration-time curve from zero to infinity [AUCinfinty; geometric means 31.8 versus 33.9 mg/L x h after test and reference, respectively; estimated true treatment ratio 94%, 90% confidence interval (CI) 90 to 98%]. The rate of absorption was slightly decreased, with a slight reduction in maximum plasma concentration (Cmax; geometric means 2.44 versus 2.87 mg/L; estimated true treatment ratio 85%, 90% CI 74 to 98%) and a prolonged time to reach Cmax (tmax; median 2.75 versus 0.88 hours). The treatments were well tolerated in these healthy individuals.

conclusionsThe effects of yoghurt on the pharmacokinetics of moxitloxacin are considered not clinically relevant. Hence, no special recommendations for administration are required when moxifloxacin is given together with dairy products.

Indexed as

Aza CompoundsDairy ProductsFluoroquinolonesQuinolinesAdministration, OralAdultAnalysis of VarianceAnti-Infective AgentsArea Under CurveBiological AvailabilityCross-Over StudiesHalf-LifeHumansIntestinal AbsorptionMaleMetabolic Clearance RateAnti-Infective AgentsAza CompoundsFluoroquinolonesMoxifloxacinQuinolines

Identifiers

PMID11352440
OpenAlexW4242988102

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.