drugset / Trial / NCT03324061

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

NCT03324061

Phase 1 Completed 600 enrolled Eagle Pharmaceuticals, Inc.
RandomizedParallel-groupOpen-labelOther

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.

Timeline

Start
2017-11-30
Primary completion
2018-07-12
Completion
2018-07-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fulvestrant Small molecule 500 mg Intramuscular

Indications

No indication recorded.