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Study · Randomized controlled trial · n = 28 · 2023

5 results

Comparing the bioequivalence and safety of liraglutide in healthy Chinese subjects: an open, single-dose, randomized, repeated, two-sequence, two-cycle phase I clinical trial.

Xu Z, Liu Z, Wang Y, Xue J, Chang T, Cui Y, Cheng Y, Liu G, Wang W, Zhou Y, Yu S, Ren Q and 7 more

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Yang W, Qu X, Chen J, Chen X, Deng Q, Yang H, Wang X

Expert review of clinical pharmacology8 Mar 2023Cited by 1 (Europe PMC)

PMID36883362 (opens in a new tab)DOI10.1080/17512433.2023.2188192 (opens in a new tab)PepBankPUB-36883362
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 study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese subjects, the geometric mean ratio of Cmax for test versus reference liraglutide was 107.11%.

    In plain wordsIn healthy Chinese adults, peak blood levels of the test liraglutide were close to those of the reference product (107.11%).

    Peptide
    Liraglutide
    Outcome
    Not applicableCmax geometric mean ratio, test vs reference
    Study

    n = 28

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

    Measurements

    Cmax GMR
    107.11%
    test vs reference

    Source sentences

    Summary
    The geometric mean ratios (GMRs) of Cmax, AUC0-t, and AUC0-∞ for the test and reference drugs were 107.11%, 106.56%, 106.09%, respectively.
    2 context sentences
    Summary · context
    Subjects (N = 28) were randomly divided into group A and group B at a ratio of 1:1 for a two-cycle cross-over study.
    Summary · context
    There was single dose per cycle with subcutaneous injection of the test and reference drugs, respectively.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese subjects, the geometric mean ratio of AUC0-t for test versus reference liraglutide was 106.56%.

    In plain wordsIn healthy Chinese adults, total exposure to the test liraglutide up to the last sample was close to the reference product (106.56%).

    Peptide
    Liraglutide
    Outcome
    Not applicableAUC0-t geometric mean ratio, test vs reference
    Study

    n = 28

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

    Measurements

    AUC0-t GMR
    106.56%
    test vs reference

    Source sentences

    Summary
    The geometric mean ratios (GMRs) of Cmax, AUC0-t, and AUC0-∞ for the test and reference drugs were 107.11%, 106.56%, 106.09%, respectively.
    2 context sentences
    Summary · context
    Subjects (N = 28) were randomly divided into group A and group B at a ratio of 1:1 for a two-cycle cross-over study.
    Summary · context
    There was single dose per cycle with subcutaneous injection of the test and reference drugs, respectively.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese subjects, the geometric mean ratio of AUC0-inf for test versus reference liraglutide was 106.09%.

    In plain wordsIn healthy Chinese adults, total exposure to the test liraglutide was close to the reference product (106.09%).

    Peptide
    Liraglutide
    Outcome
    Not applicableAUC0-inf geometric mean ratio, test vs reference
    Study

    n = 28

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

    Measurements

    AUC0-inf GMR
    106.09%
    test vs reference

    Source sentences

    Summary
    The geometric mean ratios (GMRs) of Cmax, AUC0-t, and AUC0-∞ for the test and reference drugs were 107.11%, 106.56%, 106.09%, respectively.
    2 context sentences
    Summary · context
    Subjects (N = 28) were randomly divided into group A and group B at a ratio of 1:1 for a two-cycle cross-over study.
    Summary · context
    There was single dose per cycle with subcutaneous injection of the test and reference drugs, respectively.
  4. 04HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese subjects, the 90% confidence intervals of all PK parameter ratios were within 80%-125%, meeting bioequivalence standards for test versus reference liraglutide.

    In plain wordsIn healthy Chinese adults, the test and reference liraglutide met the standard range for bioequivalence.

    Peptide
    Liraglutide
    Outcome
    No significant changeBioequivalence 90% CI within 80%-125%
    Study

    n = 28

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

    Measurements

    90% CI range
    80 to 125%
    all PK parameters

    Source sentences

    Summary
    The 90% confidence intervals (CIs) were all within 80%-125%, meeting the bioequivalence standards.
    2 context sentences
    Summary · context
    Subjects (N = 28) were randomly divided into group A and group B at a ratio of 1:1 for a two-cycle cross-over study.
    Summary · context
    There was single dose per cycle with subcutaneous injection of the test and reference drugs, respectively.
  5. 05HumanRandomized controlled trialSafety outcome

    In healthy Chinese subjects, both the test and the reference liraglutide had good safety in this trial.

    In plain wordsIn healthy Chinese adults, both liraglutide products were reported to have good safety in this trial.

    Peptide
    Liraglutide
    Outcome
    No significant changeSafety of test and reference liraglutide
    Study

    n = 28

    Comparator
    Reference liraglutide
    Outcome group
    Adverse events · Pharmacology
    Studied dose
    Dose not stated · subcutaneous · Single doseAs given in this study (human).

    Source sentences

    Summary
    In addition, both had good safety in this study.
    2 context sentences
    Summary · context
    Subjects (N = 28) were randomly divided into group A and group B at a ratio of 1:1 for a two-cycle cross-over study.
    Summary · context
    There was single dose per cycle with subcutaneous injection of the test and reference drugs, respectively.

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 1NCT05029076

Human Bioequivalence Test of Liraglutide Injection

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.n = 2821 May 2019 to 1 Jul 2019

Type 2 Diabetes

Trial pageClinicalTrials.govUpdated 31 Aug 2021

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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