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Study · Randomized controlled trial · n = 38 · 2009

9 results

Population pharmacokinetic analysis of lanreotide Autogel in healthy subjects : evidence for injection interval of up to 2 months.

Trocóniz IF, Cendrós JM, Peraire C, Ramis J, Garrido MJ, Boscani PF, Obach R

Clinical pharmacokinetics1 Jan 2009Cited by 23 (Europe PMC)

PMID19071884 (opens in a new tab)DOI10.2165/0003088-200948010-00004 (opens in a new tab)PepBankPUB-19071884
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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 study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, lanreotide Autogel absorption rate was independent of dose from 60 to 120 mg.

    In plain wordsIn healthy people, lanreotide Autogel absorption rate did not depend on dose from 60 to 120 mg.

    Peptide
    Lanreotide
    Outcome
    No significant changeDose effect on absorption rate
    Study

    n = 38

    Comparator
    Different administered doses
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    60-120 mg · deep subcutaneousAs given in this study (human).

    Source sentences

    Summary
    The rate of absorption and bioavailability of lanreotide Autogel were independent of the administered dose in the range from 60 to 120 mg, and no significant effect of covariates (sex, dose, age or bodyweight) was found (p > 0.05).
    5 context sentences
    Summary · context
    This was an open-label, single-centre, randomized, dose-ranging, parallel-group study, with a follow-up period of 4-7 months following drug administration in healthy subjects.
    Summary · context
    Healthy Caucasian subjects aged 18-45 years were included.
    Summary · context
    Subjects received a rapid intravenous bolus of 7 microg/kg of an immediate-release formulation of lanreotide (lanreotide IRF).
    Summary · context
    After a 3-day washout period, participants were randomized to receive a single deep subcutaneous injection of lanreotide Autogel at a dose of 60, 90 or 120 mg.
    Summary · context
    Data after intravenous and subcutaneous administration were fitted simultaneously using the population approach in NONMEM((R)) version VI software.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, lanreotide Autogel bioavailability was independent of dose from 60 to 120 mg.

    In plain wordsIn healthy people, lanreotide Autogel bioavailability did not depend on dose from 60 to 120 mg.

    Peptide
    Lanreotide
    Outcome
    No significant changeDose effect on bioavailability
    Study

    n = 38

    Comparator
    Different administered doses
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    60-120 mg · deep subcutaneousAs given in this study (human).

    Source sentences

    Summary
    The rate of absorption and bioavailability of lanreotide Autogel were independent of the administered dose in the range from 60 to 120 mg, and no significant effect of covariates (sex, dose, age or bodyweight) was found (p > 0.05).
    5 context sentences
    Summary · context
    This was an open-label, single-centre, randomized, dose-ranging, parallel-group study, with a follow-up period of 4-7 months following drug administration in healthy subjects.
    Summary · context
    Healthy Caucasian subjects aged 18-45 years were included.
    Summary · context
    Subjects received a rapid intravenous bolus of 7 microg/kg of an immediate-release formulation of lanreotide (lanreotide IRF).
    Summary · context
    After a 3-day washout period, participants were randomized to receive a single deep subcutaneous injection of lanreotide Autogel at a dose of 60, 90 or 120 mg.
    Summary · context
    Data after intravenous and subcutaneous administration were fitted simultaneously using the population approach in NONMEM((R)) version VI software.
  3. 03HumanNon-randomized trialPharmacokinetics

    In healthy subjects, lanreotide Autogel absorption rate was modeled to decrease exponentially with the natural logarithm of time.

    In plain wordsIn healthy people, a model described a decrease in lanreotide Autogel absorption rate over time.

    Peptide
    Lanreotide
    Outcome
    DecreaseAbsorption profile
    Study

    n = 38

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    60, 90 or 120 mg, single injection · deep subcutaneousAs given in this study (human).

    Source sentences

    Summary
    To evaluate lanreotide Autogel pharmacokinetics, the absorption rate was modelled to decrease exponentially as a function of the natural logarithm of time.
    5 context sentences
    Summary · context
    This was an open-label, single-centre, randomized, dose-ranging, parallel-group study, with a follow-up period of 4-7 months following drug administration in healthy subjects.
    Summary · context
    Healthy Caucasian subjects aged 18-45 years were included.
    Summary · context
    Subjects received a rapid intravenous bolus of 7 microg/kg of an immediate-release formulation of lanreotide (lanreotide IRF).
    Summary · context
    After a 3-day washout period, participants were randomized to receive a single deep subcutaneous injection of lanreotide Autogel at a dose of 60, 90 or 120 mg.
    Summary · context
    Data after intravenous and subcutaneous administration were fitted simultaneously using the population approach in NONMEM((R)) version VI software.
  4. 04HumanNon-randomized trialPharmacokinetics

    In healthy subjects, absolute bioavailability of deep subcutaneous lanreotide Autogel was 63%.

    In plain wordsIn healthy people, lanreotide Autogel had 63% absolute bioavailability after deep injection under the skin.

    Peptide
    Lanreotide
    Outcome
    Not applicableAbsolute bioavailability
    Study

    n = 38

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    60, 90 or 120 mg, single injection · deep subcutaneousAs given in this study (human).

    Measurements

    Absolute bioavailability
    63%
    deep subcutaneous lanreotide Autogel

    Source sentences

    Summary
    The absolute bioavailability after deep subcutaneous administration of lanreotide Autogel was 63%.
    5 context sentences
    Summary · context
    This was an open-label, single-centre, randomized, dose-ranging, parallel-group study, with a follow-up period of 4-7 months following drug administration in healthy subjects.
    Summary · context
    Healthy Caucasian subjects aged 18-45 years were included.
    Summary · context
    Subjects received a rapid intravenous bolus of 7 microg/kg of an immediate-release formulation of lanreotide (lanreotide IRF).
    Summary · context
    After a 3-day washout period, participants were randomized to receive a single deep subcutaneous injection of lanreotide Autogel at a dose of 60, 90 or 120 mg.
    Summary · context
    Data after intravenous and subcutaneous administration were fitted simultaneously using the population approach in NONMEM((R)) version VI software.
  5. 05HumanNon-randomized trialPharmacokinetics

    In healthy subjects given lanreotide, measured disposition was described by a three-compartment open model.

    In plain wordsIn healthy people given lanreotide, a three-compartment model described drug disposition.

    Peptide
    Lanreotide
    Outcome
    Not applicableDisposition model
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    7 microg/kg intravenous lanreotide IRF, followed by 60, 90 or 120 mg subcutaneous Autogel in a subset · intravenous and deep subcutaneousAs given in this study (human).

    Source sentences

    Summary
    The disposition of lanreotide was described by a three-compartment open model.
    5 context sentences
    Summary · context
    This was an open-label, single-centre, randomized, dose-ranging, parallel-group study, with a follow-up period of 4-7 months following drug administration in healthy subjects.
    Summary · context
    Healthy Caucasian subjects aged 18-45 years were included.
    Summary · context
    Subjects received a rapid intravenous bolus of 7 microg/kg of an immediate-release formulation of lanreotide (lanreotide IRF).
    Summary · context
    After a 3-day washout period, participants were randomized to receive a single deep subcutaneous injection of lanreotide Autogel at a dose of 60, 90 or 120 mg.
    Summary · context
    Data after intravenous and subcutaneous administration were fitted simultaneously using the population approach in NONMEM((R)) version VI software.
  6. 06HumanNon-randomized trialPharmacokinetics

    In healthy subjects given lanreotide, estimated total volume of distribution was 15.1 L.

    In plain wordsIn healthy people given lanreotide, estimated drug distribution volume was 15.1 L.

    Peptide
    Lanreotide
    Outcome
    Not applicableTotal volume of distribution
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    7 microg/kg intravenous lanreotide IRF, followed by 60, 90 or 120 mg subcutaneous Autogel in a subset · intravenous and deep subcutaneousAs given in this study (human).

    Measurements

    Total volume of distribution
    15.1 L
    lanreotide

    Source sentences

    Summary
    The estimates of the total volume of distribution and serum clearance were 15.1 L and 23.1 L/h, respectively.
    5 context sentences
    Summary · context
    This was an open-label, single-centre, randomized, dose-ranging, parallel-group study, with a follow-up period of 4-7 months following drug administration in healthy subjects.
    Summary · context
    Healthy Caucasian subjects aged 18-45 years were included.
    Summary · context
    Subjects received a rapid intravenous bolus of 7 microg/kg of an immediate-release formulation of lanreotide (lanreotide IRF).
    Summary · context
    After a 3-day washout period, participants were randomized to receive a single deep subcutaneous injection of lanreotide Autogel at a dose of 60, 90 or 120 mg.
    Summary · context
    Data after intravenous and subcutaneous administration were fitted simultaneously using the population approach in NONMEM((R)) version VI software.
  7. 07HumanNon-randomized trialPharmacokinetics

    In healthy subjects given lanreotide, estimated serum clearance was 23.1 L/h.

    In plain wordsIn healthy people given lanreotide, estimated serum clearance was 23.1 L/h.

    Peptide
    Lanreotide
    Outcome
    Not applicableSerum clearance
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    7 microg/kg intravenous lanreotide IRF, followed by 60, 90 or 120 mg subcutaneous Autogel in a subset · intravenous and deep subcutaneousAs given in this study (human).

    Measurements

    Serum clearance
    23.1 L/h
    lanreotide

    Source sentences

    Summary
    The estimates of the total volume of distribution and serum clearance were 15.1 L and 23.1 L/h, respectively.
    5 context sentences
    Summary · context
    This was an open-label, single-centre, randomized, dose-ranging, parallel-group study, with a follow-up period of 4-7 months following drug administration in healthy subjects.
    Summary · context
    Healthy Caucasian subjects aged 18-45 years were included.
    Summary · context
    Subjects received a rapid intravenous bolus of 7 microg/kg of an immediate-release formulation of lanreotide (lanreotide IRF).
    Summary · context
    After a 3-day washout period, participants were randomized to receive a single deep subcutaneous injection of lanreotide Autogel at a dose of 60, 90 or 120 mg.
    Summary · context
    Data after intravenous and subcutaneous administration were fitted simultaneously using the population approach in NONMEM((R)) version VI software.
  8. 08HumanNon-randomized trialPharmacokinetics

    In healthy subjects given lanreotide, estimated interindividual variability was <40%.

    In plain wordsIn healthy people given lanreotide, estimated variation between people was less than 40%.

    Peptide
    Lanreotide
    Outcome
    Not applicableInterindividual variability
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    7 microg/kg intravenous lanreotide IRF, followed by 60, 90 or 120 mg subcutaneous Autogel in a subset · intravenous and deep subcutaneousAs given in this study (human).

    Measurements

    Interindividual variability
    < 40%
    estimates

    Source sentences

    Summary
    The estimates of interindividual variability were <40%.
    5 context sentences
    Summary · context
    This was an open-label, single-centre, randomized, dose-ranging, parallel-group study, with a follow-up period of 4-7 months following drug administration in healthy subjects.
    Summary · context
    Healthy Caucasian subjects aged 18-45 years were included.
    Summary · context
    Subjects received a rapid intravenous bolus of 7 microg/kg of an immediate-release formulation of lanreotide (lanreotide IRF).
    Summary · context
    After a 3-day washout period, participants were randomized to receive a single deep subcutaneous injection of lanreotide Autogel at a dose of 60, 90 or 120 mg.
    Summary · context
    Data after intravenous and subcutaneous administration were fitted simultaneously using the population approach in NONMEM((R)) version VI software.
  9. 09HumanObservational studyPharmacokinetics

    In healthy subjects given lanreotide Autogel, sex, dose, age, and bodyweight showed no significant covariate effect, p > 0.05.

    In plain wordsIn healthy people given lanreotide Autogel, sex, dose, age, and bodyweight had no significant effect on drug handling.

    Peptide
    Lanreotide
    Outcome
    No significant changeCovariate effects on pharmacokinetics
    Study

    n = 38

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    60-120 mg · deep subcutaneousAs given in this study (human).

    Measurements

    P value for covariate effects
    > 0.05 p
    sex, dose, age, bodyweight

    Source sentences

    Summary
    The rate of absorption and bioavailability of lanreotide Autogel were independent of the administered dose in the range from 60 to 120 mg, and no significant effect of covariates (sex, dose, age or bodyweight) was found (p > 0.05).
    5 context sentences
    Summary · context
    This was an open-label, single-centre, randomized, dose-ranging, parallel-group study, with a follow-up period of 4-7 months following drug administration in healthy subjects.
    Summary · context
    Healthy Caucasian subjects aged 18-45 years were included.
    Summary · context
    Subjects received a rapid intravenous bolus of 7 microg/kg of an immediate-release formulation of lanreotide (lanreotide IRF).
    Summary · context
    After a 3-day washout period, participants were randomized to receive a single deep subcutaneous injection of lanreotide Autogel at a dose of 60, 90 or 120 mg.
    Summary · context
    Data after intravenous and subcutaneous administration were fitted simultaneously using the population approach in NONMEM((R)) version VI software.

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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, 16:36 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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