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The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women

NCT04285684 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-12-13

Study results available
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Summary

Quantification of Ketamine in Breast Milk at 3 hour Intervals up to 30 hours-- obtained from lactating women who receive 2 different Intramuscular injections of ketamine on two separate days at least 5 days apart.

Conditions

  • Ketamine
  • Lactation

Interventions

DRUG

ketamine in lactation

2 dose IM by weight and assessing concentrations of ketamine in expressed milk at intervals

Sponsors & Collaborators

  • The Ketamine Research Foundation

    lead OTHER

Principal Investigators

  • Philip E Wolfson, MD · Ketamine Research Foundation

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-20
Primary Completion
2021-01-05
Completion
2021-01-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04285684 on ClinicalTrials.gov