c4671039

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. 

Card Summary Component

誰が参加できますか

This study is seeking healthy breastfeeding female participants.

Condition

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

Age

18 - 55

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

Sex

Female

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.

Card Summary Component

実施項目

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.

compensation

€ 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.

参加に関心が

ありますか。

この治験についての詳しい情報:

0800.99.256 (フリーダイヤル:ベルギーから)、00800.26.36.26.36(フリーダイヤル:イギリス、フランス、ドイツ、オランダから)、+32.25.66.78.46(有料ダイヤル:上記以外の国から)に電話し、担当者に詳細をお問い合わせください。または、以下の登録フォームに入力してご送信ください。

「個人情報」とは名前、生年月日、電話番号、健康状態や病状など、一個人としてのあなたに関する情報を意味します。登録フォームに登録される際に当社と共有される個人情報は、医療アンケートや関連資料を送信するためにPCRUブリュッセルによって収集されます。

あなたの個人情報は、厳密に機密扱いで取り扱われ、適応されるすべての法律、特に治験に関するEUとベルギーの法律およびEUとベルギーの個人情報保護に関する法律に準拠して処理されます。

個人情報保護は私たち治験ユニットにとっても非常に重要です、そのため、https://privacycenter.pfizer.com/en/belgiumよりプライバシーに関する通知をお読みください。

 

*は必須項目です。必ずご記入ください。

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