Evidence map›Paper›PMID 18810398›Full record

Trial reportEuropean journal of clinical pharmacology2009

High absolute bioavailability of methylene blue given as an aqueous oral formulation.

Ingeborg Walter-Sack, Jens Rengelshausen, Heike Oberwittler, Juergen Burhenne, Olaf Mueller, Peter Meissner, Gerd Mikus

Open access · greenAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 3 pooled it
5.1field-weighted citation impact, top 5% 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

58 citing papers in PubMed, 3 syntheses or guidelines pooled it, 107 citations in OpenAlex.

  1. Pooled it
  2. Evaluating the safety of oral methylene blue during swallowing assessment: a systematic review.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2021
    Pooled it
  3. Pooled it
  4. Pharmacokinetics andAntimicrobial agents and chemotherapy · 2020
    Trial
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Article
  10. Real-time measurements of ATP dynamics via ATeams inAntimicrobial agents and chemotherapy · 2024
    Article
  11. Article
  12. Methylene Blue-Induced Serotonin Toxicity: Case Files of the Medical Toxicology Fellowship at the New York City Poison Control Center.Journal of medical toxicology : official journal of the American College of Medical Toxicology · 2024
    Article
  13. Article
  14. Article
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  17. Review
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  20. Article
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

7 authors at 2 institutions in 1 country.

Ingeborg Walter-SackDepartment of Internal Medicine VI, Clinical Pharmacology and Pharmacoepidemiology, University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.
Jens Rengelshausen
Heike Oberwittler
Juergen Burhenne
Olaf Mueller
Peter Meissner
Gerd Mikus
University Hospital Heidelberg · DEHeidelberg University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeMethylene blue (MB) has recently been reevaluated for malaria treatment. With the aim of excluding treatment failures due to low bioavailability, we have investigated the absolute bioavailability of MB given as an aqueous oral formulation and its interaction with chloroquine (CQ).

methodsA phase I study in 16 healthy individuals was performed as a monocenter prospective open randomized intra-individual cross-over comparison of MB single doses [50 mg intravenous (i.v.), 500 mg orally, separated by a 1-week wash-out]. After a second week, the group was split for a randomized parallel group comparison of CQ 750 mg administered orally alone or combined with 500 mg MB orally.

resultsMean MB plasma area under the substrate concentration-time curve (AUC 0-infinity) was 7,639 +/- 3,384 ng/mL*h and 51,171 +/- 17,147 ng/mL*h after i.v. and oral administration, respectively (dosage 1:10), and 76,897 +/- 46,037 ng/mL*h after MB combined with CQ. The absolute bioavailability was 72.3 +/- 23.9%. Co-administration with CQ significantly increased MB plasma concentrations (p <or= 0.016); CQ kinetics remained unaffected.

conclusionThe absolute bioavailability of MB is high. Co-administration of MB and CQ increases plasma, but not whole blood MB concentrations.

Indexed as

Biological AvailabilityAdministration, OralAdultAntimalarialsArea Under CurveChemistry, PharmaceuticalChloroquineCross-Over StudiesDrug Therapy, CombinationFemaleHalf-LifeHumansInjections, IntravenousMaleMethylene BluePlasmaAntimalarialsChloroquinechloroquine diphosphateMethylene BlueTabletsWater

Identifiers

PMID18810398
OpenAlexW2013797360

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.