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A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®

NCT03551873 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7

Last updated 2019-11-22

No results posted yet for this study

Summary

This is a multi-center, open-label study evaluating pharmacokinetics of TRULANCE® (plecanatide) in breast milk of lactating women treated with TRULANCE

Conditions

  • Chronic Idiopathic Constipation

Interventions

DRUG

Plecanatide

Subjects will have been breastfeeding or pumping for at least 4 weeks and must have been prescribed and taking TRULANCE® for at least 14 continuous days prior to Baseline. Breast milk for measurement of TRULANCE® (plecanatide) concentrations will be collected at Day 1.

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Anhthu Nguyen · Synergy Pharmaceuticals Inc.

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-21
Primary Completion
2018-12-14
Completion
2018-12-14
FDA Drug
Yes

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 NCT03551873 on ClinicalTrials.gov