Study to Evaluate the Safety, Tolerability, and PK of Fulvestrant After IM Administration

PHASE1CompletedINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

November 30, 2017

Primary Completion Date

July 12, 2018

Study Completion Date

July 12, 2018

Conditions
Pharmacokinetics
Interventions
DRUG

Fulvestrant for Injectable Suspension

Test drug is administered as a single 5mL intramuscular injection in the right or left dorsogluteal muscle area

DRUG

Faslodex (Reference)

Reference drug is administered as two 5mL intramuscular injections, one in each of the right and left dorsogluteal muscle areas

Trial Locations (12)

32720

Avail Clinical Research, LLC, DeLand

32809

Orlando Clinical Research Center, Orlando

33014

Clinical Pharmacology of Miami, LLC, Miami

33126

Quotient Sciences, Miami

33147

Advanced Pharma CR, LLC, Miami

37920

New Orleans Center for Clinical Research, Knoxville

45242

New Horizon Clinical Research, Cincinnati

78217

Worldwide Clinical Trials, San Antonio

78705

Optimal Research, LLC, Austin

89119

Clinical Research Consortium, Las Vegas

90806

Collaborative Neuroscience Network, LLC, Long Beach

08009

Hassman Research Institute, Berlin

Sponsors
All Listed Sponsors
lead

Eagle Pharmaceuticals, Inc.

INDUSTRY

NCT03324061 - Study to Evaluate the Safety, Tolerability, and PK of Fulvestrant After IM Administration | Biotech Hunter | Biotech Hunter