MedTrace Logo

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

NCT03324061 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2021-06-03

No results posted yet for this study

Summary

Clinical study designed to assess the plasma pharmacokinetic profile and tolerability of Fulvestrant for Injectable Suspension after a single IM dose of Fulvestrant for Injectable Suspension compared to the reference product, Faslodex in healthy female subjects.

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

Sponsors & Collaborators

  • Eagle Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Adrian J Hepner, MD, PhD · Eagle Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2018-07-12
Completion
2018-07-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03324061 on ClinicalTrials.gov