NCT02795039

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Fresenius Kabi · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Fulvestrant	Single 5 mL intramuscular injection (slowly over 1-2 minutes) of Fulvestrant into the right buttock (upper outer quadrant)
DRUG	Fulvestrant	Single 5 mL intramuscular injection (slowly over 1-2 minutes) of Faslodex® (Fulvestrant) into the right buttock (upper outer quadrant)

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-03-03
• Completion: 2017-03-03
• First posted: 2016-06-09
• Last updated: 2017-03-09

Locations

3 sites across 1 country: Canada