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Study · Randomized controlled trial · n = 24 · 2008

13 results

Exenatide pharmacokinetics in healthy Chinese subjects.

Zhao X, Cui YM, Zhou Y, Zhang HL, Yeo KP, Linnebjerg H, Tham LS, Kothare P, Teng LL, Mace K, Soon D

International journal of clinical pharmacology and therapeutics1 Sept 2008Cited by 6 (Europe PMC)

PMID18793576 (opens in a new tab)DOI10.5414/cpp46459 (opens in a new tab)PepBankPUB-18793576
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 study13

13 results from studies that gave the peptide. 13 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese adults, exenatide reached median peak concentrations at one hour after single and multiple doses.

    In plain wordsExenatide reached peak blood levels at one hour in healthy Chinese adults.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableTime to maximum concentration
    Study

    n = 24

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 microg and 10 microg · subcutaneous · 4 daysAs given in this study (human).

    Measurements

    Median tmax
    1 h
    single and multiple doses

    Source sentences

    Summary
    Exenatide, 5 microg and 10 microg, was rapidly absorbed with a median tmax of 1 h after single and multiple doses.
    2 context sentences
    Summary · context
    24 healthy volunteers were randomized to receive either 5 microg or 10 microg of exenatide by subcutaneous injection.
    Summary · context
    Subjects received a single injection of exenatide on Day 1, twice daily on Days 2 and 3, and once on Day 4.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese adults, exenatide half-life remained consistent across dose levels and single versus multiple dosing.

    In plain wordsExenatide half-life was similar across dose levels and dosing schedules.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeHalf-life
    Study

    n = 24

    Comparator
    Single versus multiple doses and 5 versus 10 microg
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 microg and 10 microg · subcutaneous · 4 daysAs given in this study (human).

    Measurements

    Half-life
    0.99 to 1.25 h
    range

    Source sentences

    Summary
    Mean half-life (t1/2, range 0.99 - 1.25 h), apparent volume of distribution (Vz/F, 19.2 - 22.3 l), and apparent clearance (CL/F, range 11.4 - 13.5 l/h) remained consistent between single and multiple doses and across the two dose levels.
    2 context sentences
    Summary · context
    24 healthy volunteers were randomized to receive either 5 microg or 10 microg of exenatide by subcutaneous injection.
    Summary · context
    Subjects received a single injection of exenatide on Day 1, twice daily on Days 2 and 3, and once on Day 4.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese adults, exenatide apparent distribution volume remained consistent across dose levels and dosing schedules.

    In plain wordsExenatide distribution volume was similar across dose levels and dosing schedules.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeApparent distribution volume
    Study

    n = 24

    Comparator
    Single versus multiple doses and 5 versus 10 microg
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 microg and 10 microg · subcutaneous · 4 daysAs given in this study (human).

    Measurements

    Vz/F
    19.2 to 22.3 l
    range

    Source sentences

    Summary
    Mean half-life (t1/2, range 0.99 - 1.25 h), apparent volume of distribution (Vz/F, 19.2 - 22.3 l), and apparent clearance (CL/F, range 11.4 - 13.5 l/h) remained consistent between single and multiple doses and across the two dose levels.
    2 context sentences
    Summary · context
    24 healthy volunteers were randomized to receive either 5 microg or 10 microg of exenatide by subcutaneous injection.
    Summary · context
    Subjects received a single injection of exenatide on Day 1, twice daily on Days 2 and 3, and once on Day 4.
  4. 04HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese adults, exenatide apparent clearance remained consistent across dose levels and dosing schedules.

    In plain wordsExenatide clearance was similar across dose levels and dosing schedules.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeApparent clearance
    Study

    n = 24

    Comparator
    Single versus multiple doses and 5 versus 10 microg
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 microg and 10 microg · subcutaneous · 4 daysAs given in this study (human).

    Measurements

    CL/F
    11.4 to 13.5 l/h
    range

    Source sentences

    Summary
    Mean half-life (t1/2, range 0.99 - 1.25 h), apparent volume of distribution (Vz/F, 19.2 - 22.3 l), and apparent clearance (CL/F, range 11.4 - 13.5 l/h) remained consistent between single and multiple doses and across the two dose levels.
    2 context sentences
    Summary · context
    24 healthy volunteers were randomized to receive either 5 microg or 10 microg of exenatide by subcutaneous injection.
    Summary · context
    Subjects received a single injection of exenatide on Day 1, twice daily on Days 2 and 3, and once on Day 4.
  5. 05HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese adults, exenatide accumulation ratios approached unity.

    In plain wordsRepeated exenatide dosing produced little accumulation in healthy Chinese adults.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableAccumulation ratios
    Study

    n = 24

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 microg and 10 microg · subcutaneous · 4 daysAs given in this study (human).

    Measurements

    Accumulation ratio
    ≈ 1 ratio
    approached 1.0 after single and multiple doses

    Source sentences

    Summary
    Both the accumulation ratios and linearity index approached 1.0.
    2 context sentences
    Summary · context
    24 healthy volunteers were randomized to receive either 5 microg or 10 microg of exenatide by subcutaneous injection.
    Summary · context
    Subjects received a single injection of exenatide on Day 1, twice daily on Days 2 and 3, and once on Day 4.
  6. 06HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese adults, the exenatide linearity index approached unity.

    In plain wordsThe exenatide linearity index was close to one in healthy Chinese adults.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableLinearity index
    Study

    n = 24

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 microg and 10 microg · subcutaneous · 4 daysAs given in this study (human).

    Measurements

    Linearity index
    ≈ 1 ratio
    approached 1.0 after single and multiple doses

    Source sentences

    Summary
    Both the accumulation ratios and linearity index approached 1.0.
    2 context sentences
    Summary · context
    24 healthy volunteers were randomized to receive either 5 microg or 10 microg of exenatide by subcutaneous injection.
    Summary · context
    Subjects received a single injection of exenatide on Day 1, twice daily on Days 2 and 3, and once on Day 4.
  7. 07HumanRandomized controlled trialSafety outcome

    In healthy Chinese adults, the most common exenatide adverse events were mild gastrointestinal events.

    In plain wordsThe most common exenatide side effects were mild digestive problems.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Direction not reportedGastrointestinal adverse events
    Study

    n = 24

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    5 microg and 10 microg · subcutaneous · 4 daysAs given in this study (human).

    Source sentences

    Summary
    The most common adverse events were gastrointestinal in nature and mild in severity.
    2 context sentences
    Summary · context
    24 healthy volunteers were randomized to receive either 5 microg or 10 microg of exenatide by subcutaneous injection.
    Summary · context
    Subjects received a single injection of exenatide on Day 1, twice daily on Days 2 and 3, and once on Day 4.
  8. 08HumanRandomized controlled trialSafety outcome

    In healthy Chinese adults, adverse events were more frequent with the higher exenatide dose.

    In plain wordsHealthy Chinese adults had more side effects with the higher exenatide dose.

    Peptide
    Exenatide (exendin-4)
    Outcome
    IncreaseAdverse event frequency at 10 microg
    Study

    n = 24

    Comparator
    5 microg exenatide
    Outcome group
    Adverse events · Whole body
    Studied dose
    10 microg · subcutaneous · 4 daysAs given in this study (human).

    Measurements

    Adverse events
    42%
    10 microg
    Adverse events
    8%
    5 microg (comparator)

    Source sentences

    Summary
    The frequency of adverse events increased with dose, such that 8% of subjects who received 5 microg and 42% of subjects who received 10 microg experienced adverse events.
    2 context sentences
    Summary · context
    24 healthy volunteers were randomized to receive either 5 microg or 10 microg of exenatide by subcutaneous injection.
    Summary · context
    Subjects received a single injection of exenatide on Day 1, twice daily on Days 2 and 3, and once on Day 4.
  9. 09HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese adults, the geometric mean Cmax of exenatide after multiple 5 microg doses was 145 pg/ml.

    In plain wordsAfter repeated 5 microg doses, peak exenatide blood level averaged 145 pg/ml in healthy Chinese adults.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableMaximum concentration at 5 microg
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 microg · subcutaneous · 4 daysAs given in this study (human).

    Measurements

    Cmax
    145 pg/ml
    multiple doses, 5 microg
    Cmax 90% CI
    119 to 176 pg/ml
    multiple doses, 5 microg

    Source sentences

    Summary
    Exenatide Cmax and AUCtau,ss were (geometric mean (90% CI)) 145 (119 - 176) pg/ml and 370 (297 - 460) pg x h/ml, respectively, after multiple dosing with 5 microg.
    2 context sentences
    Summary · context
    24 healthy volunteers were randomized to receive either 5 microg or 10 microg of exenatide by subcutaneous injection.
    Summary · context
    Subjects received a single injection of exenatide on Day 1, twice daily on Days 2 and 3, and once on Day 4.
  10. 10HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese adults, the geometric mean steady-state AUCtau of exenatide after multiple 5 microg doses was 370 pg x h/ml.

    In plain wordsAfter repeated 5 microg doses, overall exenatide exposure averaged 370 pg x h/ml in healthy Chinese adults.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableSteady-state exposure at 5 microg
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 microg · subcutaneous · 4 daysAs given in this study (human).

    Measurements

    AUCtau,ss
    370 pg x h/ml
    multiple doses, 5 microg
    AUCtau,ss 90% CI
    297 to 460 pg x h/ml
    multiple doses, 5 microg

    Source sentences

    Summary
    Exenatide Cmax and AUCtau,ss were (geometric mean (90% CI)) 145 (119 - 176) pg/ml and 370 (297 - 460) pg x h/ml, respectively, after multiple dosing with 5 microg.
    2 context sentences
    Summary · context
    24 healthy volunteers were randomized to receive either 5 microg or 10 microg of exenatide by subcutaneous injection.
    Summary · context
    Subjects received a single injection of exenatide on Day 1, twice daily on Days 2 and 3, and once on Day 4.
  11. 11HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese adults, the geometric mean Cmax of exenatide after multiple 10 microg doses was 311 pg/ml.

    In plain wordsAfter repeated 10 microg doses, peak exenatide blood level averaged 311 pg/ml in healthy Chinese adults.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableMaximum concentration at 10 microg
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    10 microg · subcutaneous · 4 daysAs given in this study (human).

    Measurements

    Cmax
    311 pg/ml
    multiple doses, 10 microg
    Cmax 90% CI
    271 to 357 pg/ml
    multiple doses, 10 microg

    Source sentences

    Summary
    The Cmax and AUCtau,ss were 311 (271 - 357) pg/ml and 878 (785 - 983) pg x h/ml, respectively, for 10 microg.
    2 context sentences
    Summary · context
    24 healthy volunteers were randomized to receive either 5 microg or 10 microg of exenatide by subcutaneous injection.
    Summary · context
    Subjects received a single injection of exenatide on Day 1, twice daily on Days 2 and 3, and once on Day 4.
  12. 12HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese adults, the geometric mean steady-state AUCtau of exenatide after multiple 10 microg doses was 878 pg x h/ml.

    In plain wordsAfter repeated 10 microg doses, overall exenatide exposure averaged 878 pg x h/ml in healthy Chinese adults.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableSteady-state exposure at 10 microg
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    10 microg · subcutaneous · 4 daysAs given in this study (human).

    Measurements

    AUCtau,ss
    878 pg x h/ml
    multiple doses, 10 microg
    AUCtau,ss 90% CI
    785 to 983 pg x h/ml
    multiple doses, 10 microg

    Source sentences

    Summary
    The Cmax and AUCtau,ss were 311 (271 - 357) pg/ml and 878 (785 - 983) pg x h/ml, respectively, for 10 microg.
    2 context sentences
    Summary · context
    24 healthy volunteers were randomized to receive either 5 microg or 10 microg of exenatide by subcutaneous injection.
    Summary · context
    Subjects received a single injection of exenatide on Day 1, twice daily on Days 2 and 3, and once on Day 4.
  13. 13HumanRandomized controlled trialSafety outcome

    In healthy Chinese adults, 8% of subjects who received exenatide 5 microg experienced adverse events.

    In plain wordsIn healthy Chinese adults, 8% of those given the lower 5 microg dose of exenatide had side effects.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableAdverse event frequency at 5 microg
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    5 microg · subcutaneous · 4 daysAs given in this study (human).

    Measurements

    Adverse events
    8%
    5 microg

    Source sentences

    Summary
    The frequency of adverse events increased with dose, such that 8% of subjects who received 5 microg and 42% of subjects who received 10 microg experienced adverse events.
    2 context sentences
    Summary · context
    24 healthy volunteers were randomized to receive either 5 microg or 10 microg of exenatide by subcutaneous injection.
    Summary · context
    Subjects received a single injection of exenatide on Day 1, twice daily on Days 2 and 3, and once on Day 4.

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

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

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