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Study · Randomized controlled trial · n = 32 · 2023

4 results

A Single-dose, Two-Period Crossover Bioequivalence Study Comparing Two Liraglutide Formulations in Healthy Chinese Subjects.

Feng S, Cai L, Wang X, Yu Q, Cai J, Hao W, Chen Z, Su X, Du C, Zou Q, Guo W, Du D, Hu F, Li F, Liu Y

Clinical pharmacology in drug development17 Jan 2023

PMID36648126 (opens in a new tab)DOI10.1002/cpdd.1187 (opens in a new tab)PepBankPUB-36648126
Publisher pagePubMedAsk about this study
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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 study4

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

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese volunteers, a test liraglutide biosimilar was bioequivalent to the reference product for maximum concentration (geometric mean ratio 105.7%).

    In plain wordsIn healthy volunteers, a liraglutide copy reached peak blood levels comparable to the original product.

    Peptide
    Liraglutide
    Outcome
    No significant changeCmax bioequivalence (test/reference ratio)
    Study

    n = 32

    Comparator
    Reference liraglutide
    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneous · single doseAs given in this study (human).

    Measurements

    Cmax GMR (T/R)
    105.7%
    test vs reference

    Source sentences

    Summary
    PK parameters were comparable between T and R, with GMRs of T/R for Cmax and AUC0-t being 105.7% and 107.7%, respectively, the 90%CI of which met the acceptance criteria for bioequivalence.
    1 context sentence
    Summary · context
    Thirty-two healthy volunteers were recruited in this randomized, open-label, single-dose, 2-period crossover bioequivalence study (ChiCTR2100043348).
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese volunteers, a test liraglutide biosimilar was bioequivalent to the reference product for AUC0-t (geometric mean ratio 107.7%).

    In plain wordsIn healthy volunteers, a liraglutide copy gave total drug exposure comparable to the original product.

    Peptide
    Liraglutide
    Outcome
    No significant changeAUC0-t bioequivalence (test/reference ratio)
    Study

    n = 32

    Comparator
    Reference liraglutide
    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneous · single doseAs given in this study (human).

    Measurements

    AUC0-t GMR (T/R)
    107.7%
    test vs reference

    Source sentences

    Summary
    PK parameters were comparable between T and R, with GMRs of T/R for Cmax and AUC0-t being 105.7% and 107.7%, respectively, the 90%CI of which met the acceptance criteria for bioequivalence.
    1 context sentence
    Summary · context
    Thirty-two healthy volunteers were recruited in this randomized, open-label, single-dose, 2-period crossover bioequivalence study (ChiCTR2100043348).
  3. 03HumanRandomized controlled trialSafety outcome

    In healthy Chinese volunteers, the safety profile of the test liraglutide was similar to that of the reference product.

    In plain wordsIn healthy volunteers, the safety profile of the liraglutide copy was similar to the original product.

    Peptide
    Liraglutide
    Outcome
    No significant changeSafety profile, test versus reference
    Study

    n = 32

    Comparator
    Reference liraglutide
    Analysis
    Secondary
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    We also observed a similar and favorable safety profile in the T and R arms, with adverse events being predominantly mild in severity and of gastrointestinal origin.
    1 context sentence
    Summary · context
    Thirty-two healthy volunteers were recruited in this randomized, open-label, single-dose, 2-period crossover bioequivalence study (ChiCTR2100043348).
  4. 04HumanRandomized controlled trialSafety outcome

    In healthy Chinese volunteers given liraglutide, adverse events were predominantly mild and of gastrointestinal origin.

    In plain wordsIn healthy volunteers given liraglutide, side effects were mostly mild and affected the gut.

    Peptide
    Liraglutide
    Outcome
    Not applicableAdverse event severity and type
    Study

    n = 32

    Analysis
    Secondary
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    with adverse events being predominantly mild in severity and of gastrointestinal origin.
    1 context sentence
    Summary · context
    Thirty-two healthy volunteers were recruited in this randomized, open-label, single-dose, 2-period crossover bioequivalence study (ChiCTR2100043348).

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

    12 Oct 2026, 11:11 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:05 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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