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Study · Randomized controlled trial · n = 72 · 2024

10 results

Two-Way Crossover Phase 1 Bioequivalence and Safety Studies in Healthy Adults for a Ready-to-Use, Room-Temperature, Liquid-Stable Glucagon Administered by Autoinjector, Prefilled Syringe, or Vial and Syringe.

Junaidi MK, Krecic MR, Close NC, Conoscenti V

Journal of diabetes science and technology8 Jun 2023Cited by 1 (Europe PMC)

PMID37291796 (opens in a new tab)PMCIDPMC11529056 (opens in a new tab)DOI10.1177/19322968231179164 (opens in a new tab)PepBankPUB-37291796
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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 study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy adults, GVS and G-PFS met AUC bioequivalence limits, with confidence bounds of 87.39% and 100.66%.

    In plain wordsIn healthy adults, glucagon exposure met bioequivalence limits for the vial and syringe versus prefilled syringe.

    Peptide
    Glucagon
    Outcome
    Not applicableGlucagon AUC bioequivalence: vial and syringe
    Study

    n = 40

    Comparator
    G-PFS
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1 mg · subcutaneousAs given in this study (human).

    Measurements

    AUC0-240 geometric mean ratio, 90% CI
    87.39 to 100.66%
    GVS:G-PFS

    Source sentences

    Summary
    GVS:G-PFS AUC0-240 87.39%, 100.66%
    2 context sentences
    Summary · context
    Healthy adults (N = 32) were randomly assigned to receive 1-mg glucagon as GAI or G-PFS, and then as the alternative three to seven days later.
    Summary · context
    Other healthy adults (N = 40) were randomly assigned to receive 1-mg glucagon as GVS or G-PFS, and then as the alternative two days later.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy adults, GVS and G-PFS met maximum concentration bioequivalence limits, with confidence bounds of 89.08% and 106.08%.

    In plain wordsIn healthy adults, peak glucagon concentrations met bioequivalence limits for the vial and syringe versus prefilled syringe.

    Peptide
    Glucagon
    Outcome
    Not applicableGlucagon maximum concentration bioequivalence: vial and syringe
    Study

    n = 40

    Comparator
    G-PFS
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1 mg · subcutaneousAs given in this study (human).

    Measurements

    Cmax geometric mean ratio, 90% CI
    89.08 to 106.08%
    GVS:G-PFS

    Source sentences

    Summary
    GVS:G-PFS AUC0-240 87.39%, 100.66% and Cmax 89.08%, 106.08%).
    2 context sentences
    Summary · context
    Healthy adults (N = 32) were randomly assigned to receive 1-mg glucagon as GAI or G-PFS, and then as the alternative three to seven days later.
    Summary · context
    Other healthy adults (N = 40) were randomly assigned to receive 1-mg glucagon as GVS or G-PFS, and then as the alternative two days later.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy adults, G-PFS and GAI met the AUC bioequivalence limits, with confidence bounds of 95.05% and 119.67%.

    In plain wordsIn healthy adults, glucagon exposure met bioequivalence limits for the prefilled syringe versus autoinjector.

    Peptide
    Glucagon
    Outcome
    Not applicableGlucagon AUC bioequivalence: autoinjector
    Study

    n = 32

    Comparator
    G-PFS
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1 mg · subcutaneousAs given in this study (human).

    Measurements

    AUC0-240 geometric mean ratio, 90% CI
    95.05 to 119.67%
    G-PFS:GAI

    Source sentences

    Summary
    The 90% confidence intervals (CIs) for AUC0-240 and Cmax geometric mean ratios for G-PFS to GAI and GVS to G-PFS were contained within the bounds 80% to 125% (G-PFS:GAI AUC0-240 95.05%, 119.67%
    2 context sentences
    Summary · context
    Healthy adults (N = 32) were randomly assigned to receive 1-mg glucagon as GAI or G-PFS, and then as the alternative three to seven days later.
    Summary · context
    Other healthy adults (N = 40) were randomly assigned to receive 1-mg glucagon as GVS or G-PFS, and then as the alternative two days later.
  4. 04HumanRandomized controlled trialPharmacokinetics

    In healthy adults, G-PFS and GAI met maximum concentration bioequivalence limits, with confidence bounds of 88.01% and 120.24%.

    In plain wordsIn healthy adults, peak glucagon concentrations met bioequivalence limits for the prefilled syringe versus autoinjector.

    Peptide
    Glucagon
    Outcome
    Not applicableGlucagon maximum concentration bioequivalence: autoinjector
    Study

    n = 32

    Comparator
    G-PFS
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1 mg · subcutaneousAs given in this study (human).

    Measurements

    Cmax geometric mean ratio, 90% CI
    88.01 to 120.24%
    G-PFS:GAI

    Source sentences

    Summary
    The 90% confidence intervals (CIs) for AUC0-240 and Cmax geometric mean ratios for G-PFS to GAI and GVS to G-PFS were contained within the bounds 80% to 125% (G-PFS:GAI AUC0-240 95.05%, 119.67% and Cmax 88.01%, 120.24%;
    2 context sentences
    Summary · context
    Healthy adults (N = 32) were randomly assigned to receive 1-mg glucagon as GAI or G-PFS, and then as the alternative three to seven days later.
    Summary · context
    Other healthy adults (N = 40) were randomly assigned to receive 1-mg glucagon as GVS or G-PFS, and then as the alternative two days later.
  5. 05HumanNon-randomized trialSafety outcome

    In healthy adults, at least one adverse event occurred in 25% (18/72) with G-PFS.

    In plain wordsIn healthy adults, 25% had at least one adverse event with the glucagon prefilled syringe.

    Peptide
    Glucagon
    Outcome
    Not applicableAny adverse event: G-PFS
    Study

    n = 72

    Outcome group
    Adverse events · Pharmacology
    Studied dose
    1 mg · subcutaneousAs given in this study (human).

    Measurements

    Participants with at least one AE
    25%
    G-PFS
    Participants with at least one AE
    18 participants
    G-PFS, of 72

    Source sentences

    Summary
    At least one AE occurred in 15.6% (5/32) participants with GAI, 25% (18/72) with G-PFS, and 32.5% (13/40) with GVS.
    2 context sentences
    Summary · context
    Healthy adults (N = 32) were randomly assigned to receive 1-mg glucagon as GAI or G-PFS, and then as the alternative three to seven days later.
    Summary · context
    Other healthy adults (N = 40) were randomly assigned to receive 1-mg glucagon as GVS or G-PFS, and then as the alternative two days later.
  6. 06HumanNon-randomized trialSafety outcome

    In healthy adults, at least one adverse event occurred in 32.5% (13/40) with GVS.

    In plain wordsIn healthy adults, 32.5% had at least one adverse event with glucagon from a vial and syringe.

    Peptide
    Glucagon
    Outcome
    Not applicableAny adverse event: GVS
    Study

    n = 40

    Outcome group
    Adverse events · Pharmacology
    Studied dose
    1 mg · subcutaneousAs given in this study (human).

    Measurements

    Participants with at least one AE
    32.5%
    GVS
    Participants with at least one AE
    13 participants
    GVS, of 40

    Source sentences

    Summary
    At least one AE occurred in 15.6% (5/32) participants with GAI, 25% (18/72) with G-PFS, and 32.5% (13/40) with GVS.
    2 context sentences
    Summary · context
    Healthy adults (N = 32) were randomly assigned to receive 1-mg glucagon as GAI or G-PFS, and then as the alternative three to seven days later.
    Summary · context
    Other healthy adults (N = 40) were randomly assigned to receive 1-mg glucagon as GVS or G-PFS, and then as the alternative two days later.
  7. 07HumanNon-randomized trialSafety outcome

    In healthy adults, at least one adverse event occurred in 15.6% (5/32) with GAI.

    In plain wordsIn healthy adults, 15.6% had at least one adverse event with the glucagon autoinjector.

    Peptide
    Glucagon
    Outcome
    Not applicableAny adverse event: GAI
    Study

    n = 32

    Outcome group
    Adverse events · Pharmacology
    Studied dose
    1 mg · subcutaneousAs given in this study (human).

    Measurements

    Participants with at least one adverse event
    15.6%
    GAI
    Participants with at least one adverse event
    5 participants
    GAI, 5/32

    Source sentences

    Summary
    At least one AE occurred in 15.6% (5/32) participants with GAI, 25% (18/72) with G-PFS, and 32.5% (13/40) with GVS.
    2 context sentences
    Summary · context
    Healthy adults (N = 32) were randomly assigned to receive 1-mg glucagon as GAI or G-PFS, and then as the alternative three to seven days later.
    Summary · context
    Other healthy adults (N = 40) were randomly assigned to receive 1-mg glucagon as GVS or G-PFS, and then as the alternative two days later.
  8. 08HumanNon-randomized trialSafety outcome

    In healthy adults receiving glucagon, 69 of 73 adverse events (94.5%) were mild.

    In plain wordsIn healthy adults receiving glucagon, 94.5% of adverse events were mild.

    Peptide
    Glucagon
    Outcome
    Not applicableMild adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Pharmacology
    Studied dose
    1 mg · subcutaneousAs given in this study (human).

    Measurements

    Mild AEs
    94.5%
    of 73 AEs
    Mild AEs
    69 AEs
    of 73 AEs

    Source sentences

    Summary
    Sixty-nine of 73 (94.5%) AEs were mild, and none were serious.
    2 context sentences
    Summary · context
    Healthy adults (N = 32) were randomly assigned to receive 1-mg glucagon as GAI or G-PFS, and then as the alternative three to seven days later.
    Summary · context
    Other healthy adults (N = 40) were randomly assigned to receive 1-mg glucagon as GVS or G-PFS, and then as the alternative two days later.
  9. 09HumanNon-randomized trialSafety outcome

    In healthy adults receiving glucagon, no adverse events were serious.

    In plain wordsIn healthy adults receiving glucagon, no adverse events were serious.

    Peptide
    Glucagon
    Outcome
    Not applicableSerious adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Pharmacology
    Studied dose
    1 mg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Sixty-nine of 73 (94.5%) AEs were mild, and none were serious.
    2 context sentences
    Summary · context
    Healthy adults (N = 32) were randomly assigned to receive 1-mg glucagon as GAI or G-PFS, and then as the alternative three to seven days later.
    Summary · context
    Other healthy adults (N = 40) were randomly assigned to receive 1-mg glucagon as GVS or G-PFS, and then as the alternative two days later.
  10. 10HumanNon-randomized trialSafety outcome

    In healthy adults receiving glucagon, nausea was the most common adverse event, accounting for 33/73 events (45%).

    In plain wordsIn healthy adults receiving glucagon, nausea accounted for 45% of adverse events.

    Peptide
    Glucagon
    Outcome
    Not applicableNausea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1 mg · subcutaneousAs given in this study (human).

    Measurements

    Nausea share of AEs
    45%
    of 73 AEs
    Nausea
    33 AEs
    of 73 AEs

    Source sentences

    Summary
    Nausea was the most common (33/73 [45%]).
    2 context sentences
    Summary · context
    Healthy adults (N = 32) were randomly assigned to receive 1-mg glucagon as GAI or G-PFS, and then as the alternative three to seven days later.
    Summary · context
    Other healthy adults (N = 40) were randomly assigned to receive 1-mg glucagon as GVS or G-PFS, and then as the alternative two days later.

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

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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