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A Study to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects

Postpartum Hemorrhage Clinical Trial

Official title:
A Randomized, 2-Part, Crossover Trial to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects

Clinical Trial Summary

Carbetocin is an oxytocin receptor agonist that selectively binds to receptors in the smooth muscle of the uterus, stimulates rhythmic contractions of the uterus, increases the frequency of existing contractions, and raises the tone of the uterine musculature. Carbetocin is approved in >100 countries for the prevention of postpartum hemorrhage due to uterine atony in women following cesarean or vaginal delivery. Per regulatory requirements, the current trial will evaluate the effects of high clinical exposure of carbetocin on the QT interval corrected for heart rate (QTc) as measured by ECG in healthy men and women.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05924321
Study type Interventional
Source Ferring Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date May 25, 2023
Completion date September 21, 2023
View Details
See also
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