NCT02795039View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

266

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

March 3, 2017

Study Completion Date

March 3, 2017

Conditions
Healthy
Interventions
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)

Trial Locations (3)

M1L4S4

Lambda Therapeutic Research Inc., Toronto

M9L 3A2

BioPharma Services Inc., Toronto

H3P 3P1

Algorithme Pharma Inc., Mount Royal

Sponsors

Lead Sponsor

Fresenius Kabi
All Listed Sponsors
lead

Fresenius Kabi

INDUSTRY