Bioequivalence Study of Fulvestrant Injection 50 mg/mL in Healthy Post-menopausal Female Subjects

Healthy Clinical Trial

Official title: Open-label, Two-treatment, Single Period, Parallel, Single-dose, Randomized, Fasting, Lab-blinded Bioequivalence Study of Fulvestrant 50 mg/mL Versus Faslodex®, 50 mg/mL, in Healthy, Post-menopausal Female Subjects

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT02795039
• Study type: Interventional
• Source: Fresenius Kabi
• Status: Completed
• Phase: Phase 1
• Start date: June 2016
• Completion date: March 3, 2017