Trial reportClinical pharmacokinetics2001
Effect of food on the pharmacokinetics of a single oral dose of moxifloxacin 400mg in healthy male volunteers.
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 16 papers, 1 of them a synthesis that pooled 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.
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.
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
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.
- Together or Apart? Revealing the Impact of Dietary Interventions on Bioavailability of Quinolones: A Systematic Review with Meta-analyses.Clinical pharmacokinetics · 2024Pooled it
- Prediction of Moxifloxacin Concentrations in Tuberculosis Patient Populations by Physiologically Based Pharmacokinetic Modeling.Journal of clinical pharmacology · 2022Trial
- Absence of ethnic differences in the pharmacokinetics of moxifloxacin, simvastatin, and meloxicam among three East Asian populations and Caucasians.British journal of clinical pharmacology · 2016Trial
- Tafenoquine at therapeutic concentrations does not prolong Fridericia-corrected QT interval in healthy subjects.Journal of clinical pharmacology · 2014Trial
- Thorough QT study of the effect of oral moxifloxacin on QTc interval in the fed and fasted state in healthy Japanese and Caucasian subjects.British journal of clinical pharmacology · 2014Trial
- Lack of effect of dalcetrapib on QT interval in healthy subjects following multiple dosing.European journal of clinical pharmacology · 2010Trial
- [Oral antibiotics: even in severe infections?]Innere Medizin (Heidelberg, Germany) · 2026Review
- Clinical standards for the dosing and management of TB drugs.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2022Article
- Moxifloxacin Pharmacokinetics, Cardiac Safety, and Dosing for the Treatment of Rifampicin-Resistant Tuberculosis in Children.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Article
- A Review of Moxifloxacin for the Treatment of Drug-Susceptible Tuberculosis.Journal of clinical pharmacology · 2017Review
- Physicochemical properties of dietary phytochemicals can predict their passive absorption in the human small intestine.Scientific reports · 2017Article
- Predicting effect of food on extent of drug absorption based on physicochemical properties.Pharmaceutical research · 2007Article
- Moxifloxacin in the treatment of skin and skin structure infections.Therapeutics and clinical risk management · 2006Article
- In vitro postantibiotic effects of rifapentine, isoniazid, and moxifloxacin against Mycobacterium tuberculosis.Antimicrobial agents and chemotherapy · 2004Article
- Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo investigate the effects of concomitant food intake on the pharmacokinetics of a single oral dose of moxifloxacin 400mg.
designThis was a randomised 2-way nonblinded crossover study in healthy volunteers.
participants18 young, healthy, male volunteers were enrolled in the study, of whom 16 were considered evaluable for the pharmacokinetic analysis.
methodsMoxifloxacin 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 (AUCinfinity) and elimination half-life (t1/2z) 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.
resultsThe mean serum concentration versus time profiles were similar between the 2 treatments. The geometric mean AUCinfinity values under fed and fasted conditions were almost identical, 37.7 versus 38.5 mg/L x 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.
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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.