Skip to content

Study · Non-randomized trial · 2023

2 results

Pharmacokinetics and Safety of Long-Acting Release Formulations of Pasireotide (SOM230) in a Male Population Who Are Hyperendemic Hepatitis B/C and Chronic Kidney Disease: An Open-Label, Phase I Study.

Huang CJ, Lu CH, Shih KC

European journal of drug metabolism and pharmacokinetics26 Sept 2023

PMID37751056 (opens in a new tab)DOI10.1007/s13318-023-00854-4 (opens in a new tab)PepBankPUB-37751056
Publisher pagePubMedAsk about this study
Jump to 2 results

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 study2

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanNon-randomized trialPharmacokinetics

    In male Taiwanese volunteers from a population hyperendemic for hepatitis B/C and CKD, pasireotide reached maximum plasma concentration 0.5 h after subcutaneous injection(s) of 300-900 µg.

    In plain wordsIn male Taiwanese volunteers from a hepatitis B/C- and CKD-hyperendemic population, subcutaneous pasireotide reached peak blood concentration at 0.5 h.

    Peptide
    Pasireotide
    Outcome
    Not applicableTime to maximum concentration after SC injection
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    300-900 µg · subcutaneousAs given in this study (human).

    Measurements

    Tmax
    0.5 h
    after SC injection(s) of pasireotide 300-900 µg

    Source sentences

    Summary
    Analysis of plasma concentration over time revealed a rapid absorption of pasireotide, with a maximal concentration at 0.5 h after SC injection(s) of pasireotide (300-900 µg).
    1 context sentence
    Summary · context
    Therefore, this open-label, phase I study aimed to evaluate the pharmacokinetic profiles and safety of subcutaneous (SC) and long-acting release (LAR) intramuscular injections of pasireotide in male Taiwanese volunteers who are hyperendemic hepatitis B/C and chronic kidney disease (CKD).
  2. 02HumanNon-randomized trialPharmacokinetics

    In male Taiwanese volunteers from a population hyperendemic for hepatitis B/C and CKD, pasireotide LAR release increased on day 1, plateaued around day 20, then declined over the next 7 weeks.

    In plain wordsIn male Taiwanese volunteers from a hepatitis B/C- and CKD-hyperendemic population, pasireotide LAR release plateaued around day 20, then declined.

    Peptide
    Pasireotide
    Outcome
    Not applicableLAR release profile
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    20-60 mg · intramuscular · single doseAs given in this study (human).

    Measurements

    Time of initial increase
    1 day
    pasireotide LAR 20-60 mg single dose
    Time of plateau
    ≈ 20 day
    pasireotide LAR 20-60 mg single dose
    Decline period
    7 weeks
    after plateau, pasireotide LAR 20-60 mg

    Source sentences

    Summary
    Following a single dose of pasireotide LAR (20-60 mg), a sustained release was observed following an initial increase on day 1, a plateau around day 20, and a decline over the next 7 weeks.
    1 context sentence
    Summary · context
    Therefore, this open-label, phase I study aimed to evaluate the pharmacokinetic profiles and safety of subcutaneous (SC) and long-acting release (LAR) intramuscular injections of pasireotide in male Taiwanese volunteers who are hyperendemic hepatitis B/C and chronic kidney disease (CKD).

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, 16:34 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.