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Study · Randomized controlled trial · n = 54 · 2018

4 results

A randomized study investigating the effect of omeprazole on the pharmacokinetics of oral semaglutide.

Bækdal TA, Breitschaft A, Navarria A, Hansen CW

Expert opinion on drug metabolism & toxicology30 Jun 2018Cited by 48 (Europe PMC)

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 study4

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, omeprazole co-administration did not significantly change oral semaglutide AUC0-24h at day 10 (ratio 1.13, 90%CI 0.88, 1.45).

    In plain wordsIn healthy people, taking omeprazole with oral semaglutide did not significantly change how much semaglutide was absorbed, compared with oral semaglutide alone.

    Outcome
    No significant changeSemaglutide AUC0-24h at day 10
    Study

    n = 54

    Comparator
    Oral semaglutide alone
    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Measurements

    AUC0-24h treatment ratio
    1.13 ratio
    oral semaglutide plus omeprazole vs alone

    Source sentences

    Summary
    Exposure of semaglutide appeared to be slightly increased, although not statistically significantly, with oral semaglutide plus omeprazole versus oral semaglutide alone (AUC0-24h,semaglutide,Day10 [estimated treatment ratio 1.13; 90%CI 0.88, 1.45] and Cmax,semaglutide,Day10 [es…
    1 context sentence
    Summary · context
    A single-center, randomized, open-label, parallel-group trial investigated pharmacokinetic interactions of oral semaglutide with omeprazole (40 mg once-daily) in 54 healthy subjects.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, omeprazole co-administration did not significantly change oral semaglutide Cmax at day 10 (ratio 1.16, 90%CI 0.90, 1.49).

    In plain wordsIn healthy people, omeprazole did not significantly change the peak semaglutide level after oral semaglutide, compared with oral semaglutide alone.

    Outcome
    No significant changeSemaglutide Cmax at day 10
    Study

    n = 54

    Comparator
    Oral semaglutide alone
    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Measurements

    Cmax treatment ratio
    1.16 ratio
    oral semaglutide plus omeprazole vs alone

    Source sentences

    Summary
    Exposure of semaglutide appeared to be slightly increased, although not statistically significantly, with oral semaglutide plus omeprazole versus oral semaglutide alone (AUC0-24h,semaglutide,Day10 [estimated treatment ratio 1.13; 90%CI 0.88, 1.45] and Cmax,semaglutide,Day10 [es…
    1 context sentence
    Summary · context
    A single-center, randomized, open-label, parallel-group trial investigated pharmacokinetic interactions of oral semaglutide with omeprazole (40 mg once-daily) in 54 healthy subjects.

Studies that did not test the peptide alone2

In this study, Semaglutide 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 Semaglutide.

  1. 03HumanNot a test of Semaglutide aloneRandomized controlled trialMechanism

    In healthy subjects, gastric pH was higher with oral semaglutide plus omeprazole than with oral semaglutide alone.

    In plain wordsIn healthy people, stomach pH was higher with omeprazole added to oral semaglutide than with oral semaglutide alone.

    Outcome
    IncreaseGastric pH
    Study

    n = 54

    Comparator
    Oral semaglutide alone
    Outcome group
    Pharmacokinetics · Pharmacology

    Source sentences

    Summary
    Gastric pH was higher with oral semaglutide and omeprazole versus oral semaglutide alone.
    1 context sentence
    Summary · context
    A single-center, randomized, open-label, parallel-group trial investigated pharmacokinetic interactions of oral semaglutide with omeprazole (40 mg once-daily) in 54 healthy subjects.

    In this study, Semaglutide 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 Semaglutide.

  2. 04HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome

    In healthy subjects, adverse events with oral semaglutide and omeprazole were mild or moderate and mostly gastrointestinal.

    In plain wordsIn healthy people, side effects were mild or moderate and mostly affected the digestive system.

    Outcome
    Not applicableAdverse events
    Study

    n = 54

    Outcome group
    Adverse events · Gastrointestinal

    Source sentences

    Summary
    Adverse events were mild or moderate and, most commonly, gastrointestinal disorders.
    1 context sentence
    Summary · context
    A single-center, randomized, open-label, parallel-group trial investigated pharmacokinetic interactions of oral semaglutide with omeprazole (40 mg once-daily) in 54 healthy subjects.

    In this study, Semaglutide 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 Semaglutide.

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

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT02249871

Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

Novo Nordisk A/Sn = 5424 Sept 2014 to 1 Apr 2015

Diabetes · Healthy

Trial pageClinicalTrials.govUpdated 13 Aug 2018

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

    11 Oct 2026, 00:50 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:06 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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