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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


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

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