The purpose is to find out how much medication is in breastmilk after intake.

This will help us determine the daily dose a child could potentially be exposed to during breastfeeding, if the nursing mother must take this medicinal product. 

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This study is seeking healthy breastfeeding female participants.


Healthy lactating women who agree to temporally interrupt breastfeeding their child for 4.5 days


18 - 55

The age a person must be to participate in a clinical trial



The sex of people who may participate in a clinical trial. Sex is a person's classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

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The study is planned to last for approximately 9 weeks.

Several examinations or procedures will be required in connection with the study:

  1. A screening examination, during which you will sign a COVID ICD and the study ICD;
  2. COVID-19 assessments during residence in the PCRU
  3. One treatment period organized of 5 days and 4 nights in the PCRU (from Day -1 to Day 4).
  4. The follow-up phone call will take place 28 to 35 days after the last administration of the study medicine.

You will not personally derive any benefit from your participation in this study, but the results obtained could be very important for the development of medicines and treatments which will benefit other people.

Long-term follow-up

a follow-up call at the end of the study

Some studies require the study team to stay in contact with the participant for a period of time after he or she completes the main part of the study. This long-term follow up is to collect additional information on the study drug over time.

How long is the study?

Approximately 9 weeks

The length of the study includes the time from screening until the final follow-up call or study activity. There may be up to 28 days between screening and dosing.


€ 1.670 upon completion of the study, €120 Covid and transportation fees

Participants in clinical trials at the PCRU receive financial compensation for their participation. The amount depends on factors like length of the stay, total number of study visits, and the nature of the study procedures.




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