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Study · Randomized controlled trial · n = 16 · 2009

6 results

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

Walter-Sack I, Rengelshausen J, Oberwittler H, Burhenne J, Mueller O, Meissner P, Mikus G

European journal of clinical pharmacology23 Sept 2008Cited by 85 (Europe PMC)

PMID18810398 (opens in a new tab)DOI10.1007/s00228-008-0563-x (opens in a new tab)PepBankPUB-18810398
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy individuals, a single 50 mg intravenous methylene blue dose gave a mean plasma AUC 0-infinity of 7,639 ng/mL*h.

    In plain wordsIn healthy individuals, intravenous methylene blue gave a mean blood exposure (AUC) of 7,639 ng/mL*h.

    Peptide
    Methylene blue
    Outcome
    Not applicableIntravenous plasma AUC
    Study

    n = 16

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    50 mg · intravenous · Single doseAs given in this study (human).

    Measurements

    AUC 0-infinity
    7639 ng/mL*h
    intravenous 50 mg, mean (+/- 3,384)

    Source sentences

    Summary
    Mean 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.
    2 context sentences
    Summary · context
    A 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].
    Summary · context
    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.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy individuals, a single 500 mg oral methylene blue dose gave a mean plasma AUC 0-infinity of 51,171 ng/mL*h.

    In plain wordsIn healthy individuals, oral methylene blue gave a mean blood exposure (AUC) of 51,171 ng/mL*h.

    Peptide
    Methylene blue
    Outcome
    Not applicableOral plasma AUC
    Study

    n = 16

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    500 mg · oral · Single doseAs given in this study (human).

    Measurements

    AUC 0-infinity
    51,171 ng/mL*h
    oral 500 mg, mean (+/- 17,147)

    Source sentences

    Summary
    Mean 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.
    2 context sentences
    Summary · context
    A 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].
    Summary · context
    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.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy individuals, aqueous oral methylene blue had high absolute bioavailability.

    In plain wordsIn healthy individuals, aqueous oral methylene blue had high availability in the body.

    Peptide
    Methylene blue
    Outcome
    Not applicableAbsolute bioavailability
    Study

    n = 16

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    500 mg oral and 50 mg intravenous · oral and intravenous · Single doseAs given in this study (human).

    Measurements

    Absolute bioavailability
    72.3%
    mean (+/- 23.9)

    Source sentences

    Summary
    The absolute bioavailability was 72.3 +/- 23.9%.
    2 context sentences
    Summary · context
    A 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].
    Summary · context
    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.
  4. 04HumanRandomized controlled trialPharmacokinetics

    In healthy individuals, adding methylene blue did not affect chloroquine kinetics versus chloroquine alone.

    In plain wordsIn healthy individuals, adding methylene blue did not change chloroquine processing compared with chloroquine alone.

    Peptide
    Methylene blue
    Outcome
    No significant changeChloroquine kinetics
    Study

    n: not reported in source

    Comparator
    Chloroquine alone
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    500 mg · oral · Single doseAs given in this study (human).

    Source sentences

    Summary
    Co-administration with CQ significantly increased MB plasma concentrations (p <or= 0.016); CQ kinetics remained unaffected.
    2 context sentences
    Summary · context
    A 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].
    Summary · context
    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.

Studies that did not test the peptide alone2

In this study, Methylene blue was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Methylene blue.

  1. 05HumanNot a test of Methylene blue aloneRandomized controlled trialPharmacokinetics

    In healthy individuals, methylene blue combined with chloroquine gave a mean plasma AUC 0-infinity of 76,897 ng/mL*h.

    In plain wordsIn healthy individuals, methylene blue taken with chloroquine gave a mean blood exposure (AUC) of 76,897 ng/mL*h.

    Peptide
    Methylene blue
    Outcome
    Not applicablePlasma AUC with chloroquine
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology

    Measurements

    AUC 0-infinity
    76,897 ng/mL*h
    oral MB combined with CQ, mean (+/- 46,037)

    Source sentences

    Summary
    Mean 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.
    2 context sentences
    Summary · context
    A 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].
    Summary · context
    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.

    In this study, Methylene blue was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Methylene blue.

  2. 06HumanNot a test of Methylene blue aloneRandomized controlled trialPharmacokinetics

    In healthy individuals, chloroquine co-administration increased methylene blue plasma concentrations versus methylene blue alone.

    In plain wordsIn healthy individuals, chloroquine with methylene blue increased methylene blue plasma concentrations compared with methylene blue alone.

    Peptide
    Methylene blue
    Outcome
    IncreaseMethylene blue plasma concentrations with chloroquine
    Study

    n: not reported in source

    Comparator
    Methylene blue alone
    Outcome group
    Pharmacokinetics · Pharmacology

    Source sentences

    Summary
    Co-administration with CQ significantly increased MB plasma concentrations (p <or= 0.016); CQ kinetics remained unaffected.
    2 context sentences
    Summary · context
    A 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].
    Summary · context
    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.

    In this study, Methylene blue was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Methylene blue.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    14 Oct 2026, 05:02 UTC

    Study results updated

  2. Version 1

    14 Oct 2026, 01:46 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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