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Study to Evaluate the Safety, Tolerability, and PK of Fulvestrant After IM Administration

Pharmacokinetics Clinical Trial

Official title:
A Phase 1, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Fulvestrant (Test vs. Reference) Following Intramuscular Administration to the Gluteal Muscle in Healthy Female Subjects

Clinical Trial Summary

Clinical study designed to assess the plasma pharmacokinetic profile and tolerability of Fulvestrant for Injectable Suspension after a single IM dose of Fulvestrant for Injectable Suspension compared to the reference product, Faslodex in healthy female subjects.

Clinical Trial Description

This is a Phase 1, open-label, parallel group study in healthy female subjects. The study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single dose of Fulvestrant for Injectable Suspension vs. the reference drug, Faslodex, administered in the gluteal muscle. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03324061
Study type Interventional
Source Eagle Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 1
Start date November 30, 2017
Completion date July 12, 2018
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