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

Chronic Idiopathic Constipation Clinical Trial

Official title:
A Phase 4 Open-label, Non-randomized Study Evaluating the Pharmacokinetics and Safety of TRULANCE® (Plecanatide) in Breast Milk of Lactating Women Treated With TRULANCE

Clinical Trial Summary

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

Clinical Trial Description

This is an open-label study in lactating women who have been prescribed TRULANCE® by their healthcare provider. The study will assess the pharmacokinetics of plecanatide and its active metabolite in breast milk of lactating women treated therapeutically with TRULANCE. Subjects will be screened prior to admission for Baseline assessments. Following final qualifications, the morning dose of TRULANCE will be administered under supervision from study personnel and serial samples of breast milk will be collected via breast pump. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03551873
Study type Observational
Source Bausch Health Americas, Inc.
Contact
Status Completed
Phase
Start date June 21, 2018
Completion date December 14, 2018
View Details
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