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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
600
Test drug is administered as a single 5mL intramuscular injection in the right or left dorsogluteal muscle area
Reference drug is administered as two 5mL intramuscular injections, one in each of the right and left dorsogluteal muscle areas
Collaborative Neuroscience Network, LLC
Long Beach, California, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States
Pharmacokinetic parameters
Area under the concentration-time curve(AUC)
Time frame: Day 0 through Day 140
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Quotient Sciences
Miami, Florida, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Clinical Research Consortium
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
New Horizon Clinical Research
Cincinnati, Ohio, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
...and 2 more locations