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Drug Concentrations in Breast Milk and Prediction of Blood Levels of the Breastfed Infants

NCT05543122 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 39

Last updated 2024-04-10

No results posted yet for this study

Summary

There is a significant lack of information on drug secretion into milk and infant exposure. As a first step to address this issue, the investigators examine milk concentrations of selected drugs prescribed to breastfeeding women, which lack milk excretion data. Milk data will be analyzed using population pharmacokinetic approaches, when possible, and acquired data of drug concentration profiles in milk will be combined with infant physiologically-based pharmacokinetic (PBPK) models to predict infant exposure levels.

Conditions

  • Breast Feeding

Interventions

DRUG

either of Atenolol, Bupropion, Brivaracetam, Escitalopram, Fluconazole, Lacosamide, Lamotrigine, Levetiracetam, Methotrexate or Ezetimibe

This is a cohort study of pharmacokinetics of drugs in milk. Participants in the group are those breastfeeding women on the listed drugs at steady state, who are prescribed these drugs for clinical reasons outside this study framework.

Sponsors & Collaborators

  • St. Justine's Hospital

    collaborator OTHER

  • University of Waterloo

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2023-12-23
Completion
2024-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05543122 on ClinicalTrials.gov