A Study to Assess the Transfer of Fospropofol and Its Active Metabolite, Propofol, to Breast Milk Following Administration of LUSEDRA to Lactating Women Undergoing a Needed Procedure

Phase 1 Completed 10 enrolled Eisai Inc.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the transfer of fospropofol and its active metabolite, propofol, to breast milk following administration of LUSEDRA® to lactating women undergoing a needed procedure.

Timeline

Start: 2010-11
Primary completion: 2012-10
Completion: 2012-10

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Propofol	Small molecule	—	—
Comparator	fospropofol	Small molecule	—	—

A Study to Assess the Transfer of Fospropofol and Its Active Metabolite, Propofol, to Breast Milk Following Administration of LUSEDRA to Lactating Women Undergoing a Needed Procedure

Summary

Timeline

Drugs

Indications