The purpose of this study is to demonstrate bioequivalence between the test drug product, fulvestrant Injection, 50 mg/mL, and the Reference Listed Drug, Faslodex® Injection, 50 mg/mL.
This study is being conducted to establish bioequivalence between sponsor's test product \[fulvestrant Injection, 50 mg/mL (Manufactured for Fresenius Kabi, USA)\] and reference listed drug \[Faslodex® Injection, 50 mg/mL, (Distributed by AstraZeneca Pharmaceuticals, USA\] after intramuscular administration of a 250 mg dose (5 mL injection) into the upper outer quadrant of the right buttock to normal, healthy, nonsmoking post-menopausal female subjects. The order of receiving the test product (T) or reference listed drug (R) for each subject during the study will be determined according to a randomization schedule. Subjects will be allocated with a ratio of 1:1 to both treatment groups (i.e. T and R).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
266
Single 5 mL intramuscular injection (slowly over 1-2 minutes) of Fulvestrant into the right buttock (upper outer quadrant)
Single 5 mL intramuscular injection (slowly over 1-2 minutes) of Faslodex® (Fulvestrant) into the right buttock (upper outer quadrant)
Lambda Therapeutic Research Inc.
Toronto, Ontario, Canada
BioPharma Services Inc.
Toronto, Ontario, Canada
Algorithme Pharma Inc.
Mount Royal, Quebec, Canada
Maximum observed plasma concentration
Time frame: 0-238 days
Area under the plasma concentration versus time curve (AUC0-238d) of fulvestrant
Time frame: 0-238 days
Area under the plasma concentration versus time curve (AUC0-28d) of fulvestrant
Time frame: 0-28 day
Area under the plasma concentration versus time curve from time zero to the last measurable concentration (AUC0-t)
Time frame: 0-238 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC0-∞)
Time frame: 0-238 days
Time to Reach the Maximum Plasma Concentration (Tmax)
Time frame: 0-238 days
Elimination Half-life Period (t1/2)
Time frame: 0-238 days
Terminal Slope (λz)
Time frame: 0-238 days
Residual area in percentage (AUC_%Extrap_obs)
Time frame: 0-238 days
Injection site pain assessment
Time frame: 0-8 days
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