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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

NCT01309984 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-11-03

No results posted yet for this study

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.

Conditions

  • Lactating Women

Interventions

DRUG

Lusedra

Pretreatment Phase - approximately 3 hours (Baseline) • Treatment Phase - approximately 8 days (includes Treatment, Discharge \[up to 24 hours\], and Follow-up Telephone Call on Day 8 post-dose after Discharge)

DRUG

Propofol

Pretreatment Phase - approximately 3 hours (Baseline) • Treatment Phase - approximately 8 days (includes Treatment, Discharge \[up to 24 hours\], and Follow-up Telephone Call on Day 8 post-dose after Discharge)

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Christa Nagy · Eisai Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

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 NCT01309984 on ClinicalTrials.gov