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Study · Randomized controlled trial · n = 26 · 2021

7 results

Relationship Between Oral Semaglutide Tablet Erosion and Pharmacokinetics: A Pharmacoscintigraphic Study.

Baekdal TA, Donsmark M, Hartoft-Nielsen ML, Søndergaard FL, Connor A

Clinical pharmacology in drug development22 Mar 2021Cited by 26 (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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy men, complete erosion of the oral semaglutide tablet occurred in the stomach with both 50 and 240 mL water.

    In plain wordsIn healthy men, the oral semaglutide tablet broke down fully in the stomach with both small and large water volumes.

    Outcome
    No significant changeComplete tablet erosion location
    Study

    n = 26

    Comparator
    Oral semaglutide with 240 mL water
    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    10 mg single dose · oral · single doseAs given in this study (human).

    Source sentences

    Summary
    Complete tablet erosion (CTE) occurred in the stomach irrespective of water volume administered with the tablet (primary end point).
    1 context sentence
    Summary · context
    In a randomized, single-center (Quotient Sciences, UK), open-label, 2-period crossover trial, 26 healthy men received single doses of 10 mg oral semaglutide with 50 or 240 mL water while fasting.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy men, mean time to complete tablet erosion was 85 min with 50 mL water and 57 min with 240 mL, without a significant difference.

    In plain wordsIn healthy men, the tablet took longer to erode with 50 mL than 240 mL of water, but the difference was not significant.

    Outcome
    No significant changeTime to complete tablet erosion
    Study

    n = 26

    Comparator
    Oral semaglutide with 240 mL water
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    10 mg single dose · oral · single doseAs given in this study (human).

    Measurements

    Time to CTE
    85 min
    50 mL water
    Time to CTE
    57 min
    240 mL water

    Source sentences

    Summary
    Mean time to CTE was 85 versus 57 minutes with 50 versus 240 mL water (ratio 50/240 mL, 1.51; 95% confidence interval, 0.96-2.37; P = .072).
    1 context sentence
    Summary · context
    In a randomized, single-center (Quotient Sciences, UK), open-label, 2-period crossover trial, 26 healthy men received single doses of 10 mg oral semaglutide with 50 or 240 mL water while fasting.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy men, semaglutide AUC0-24h was about 70% higher with 50 mL than with 240 mL water, not significant at P = .056.

    In plain wordsIn healthy men, semaglutide exposure was about 70% higher with less water, but the difference was not significant.

    Outcome
    No significant changeSemaglutide AUC 0-24h
    Study

    n = 26

    Comparator
    Oral semaglutide with 240 mL water
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    10 mg single dose · oral · single doseAs given in this study (human).

    Measurements

    AUC0-24h difference
    ≈ 70%
    50 vs 240 mL water

    Source sentences

    Summary
    Area under the semaglutide concentration-time curve from 0 to 24 hours (AUC0-24h,semaglutide ) and maximum semaglutide concentration (Cmax,semaglutide ) were ∼70% higher with 50 versus 240 mL water (P = .056 and P = .048, respectively).
    1 context sentence
    Summary · context
    In a randomized, single-center (Quotient Sciences, UK), open-label, 2-period crossover trial, 26 healthy men received single doses of 10 mg oral semaglutide with 50 or 240 mL water while fasting.
  4. 04HumanRandomized controlled trialPharmacokinetics

    In healthy men, maximum semaglutide concentration was about 70% higher with 50 mL than with 240 mL water (P = .048).

    In plain wordsIn healthy men, peak semaglutide levels were about 70% higher with less water than with more water.

    Outcome
    IncreaseSemaglutide Cmax
    Study

    n = 26

    Comparator
    Oral semaglutide with 240 mL water
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    10 mg single dose · oral · single doseAs given in this study (human).

    Measurements

    Cmax difference
    ≈ 70%
    50 vs 240 mL water

    Source sentences

    Summary
    Area under the semaglutide concentration-time curve from 0 to 24 hours (AUC0-24h,semaglutide ) and maximum semaglutide concentration (Cmax,semaglutide ) were ∼70% higher with 50 versus 240 mL water (P = .056 and P = .048, respectively).
    1 context sentence
    Summary · context
    In a randomized, single-center (Quotient Sciences, UK), open-label, 2-period crossover trial, 26 healthy men received single doses of 10 mg oral semaglutide with 50 or 240 mL water while fasting.
  5. 05HumanRandomized controlled trialPharmacokinetics

    In healthy men, median tmax of semaglutide was 1.5 hours regardless of water volume.

    In plain wordsIn healthy men, semaglutide reached its peak level after 1.5 hours whatever the water volume.

    Outcome
    No significant changeTime to maximum semaglutide concentration
    Study

    n = 26

    Comparator
    Oral semaglutide with 240 mL water
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    10 mg single dose · oral · single doseAs given in this study (human).

    Measurements

    Median tmax
    1.5 hours
    both water volumes

    Source sentences

    Summary
    Median time to maximum semaglutide concentration (tmax,semaglutide ) was 1.5 hours independent of water volume with dosing.
    1 context sentence
    Summary · context
    In a randomized, single-center (Quotient Sciences, UK), open-label, 2-period crossover trial, 26 healthy men received single doses of 10 mg oral semaglutide with 50 or 240 mL water while fasting.
  6. 06HumanRandomized controlled trialMechanism

    In healthy men, higher semaglutide AUC and Cmax and longer tmax correlated with longer time to complete tablet erosion and later gastric emptying.

    In plain wordsIn healthy men, slower tablet breakdown and later stomach emptying were linked to higher semaglutide levels in blood.

    Outcome
    Not applicableCorrelation of semaglutide exposure with tablet erosion time and gastric emptying
    Study

    n = 26

    Comparator
    Oral semaglutide with 240 mL water
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    10 mg single dose · oral · single doseAs given in this study (human).

    Source sentences

    Summary
    Higher AUC0-24h,semaglutide and Cmax,semaglutide and longer tmax,semaglutide were significantly correlated with longer time to CTE and later gastric emptying of tablet and water (all P < .05).
    1 context sentence
    Summary · context
    In a randomized, single-center (Quotient Sciences, UK), open-label, 2-period crossover trial, 26 healthy men received single doses of 10 mg oral semaglutide with 50 or 240 mL water while fasting.
  7. 07HumanRandomized controlled trialSafety outcome

    In healthy men, the safety profile of oral semaglutide was as expected for the GLP-1 receptor agonist class.

    In plain wordsIn healthy men, oral semaglutide safety was as expected for this drug class.

    Outcome
    Not applicableSafety profile
    Study

    n = 26

    Outcome group
    Adverse events · Pharmacology
    Studied dose
    10 mg single dose · oral · single doseAs given in this study (human).

    Source sentences

    Summary
    The safety profile was as expected for the GLP-1 receptor agonist drug class.
    1 context sentence
    Summary · context
    In a randomized, single-center (Quotient Sciences, UK), open-label, 2-period crossover trial, 26 healthy men received single doses of 10 mg oral semaglutide with 50 or 240 mL water while fasting.

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

    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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