Study identification

PURI

https://redirect.ema.europa.eu/resource/103390

EU PAS number

EUPAS103385

Study ID

103390

Official title and acronym

Prediction of venlafaxine exposure through breastfeeding

DARWIN EU® study

No

Study countries

Switzerland

Study description

The exposure of infants to drugs through breastmilk can be highly variable and depends on the dose ingested by the child along with the absorption, the distribution, the metabolism and the elimination of the drug by the child. Characterisation of this exposure is essential to provide recommendations for preventing toxicity in breastfed infants and assuring mother’s adequate treatment. This can be achieved by assessing the physicochemical and pharmacokinetic properties of the drugs and inter-individual variability due to characteristics of the mothers and breastfed infants. This study will allow suppling a European biobank located in Uppsala with samples of breast milk, from breastfeeding women taking venlafaxine provided by participants in Switzerland.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Alice Panchaud

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

H2020-Grant - Innovative medicine initiative call 13 topic 9 « ConcePTION »
Study protocol
Initial protocol

4. Protocole_Venlafaxine_20210709_v5

English (1.96 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Non-EU RMP only