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COMPLETED Phase 1

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

NCT03324061 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG Fulvestrant for Injectable Suspension
  • DRUG Faslodex (Reference)

Study Locations (12)

Florida

  • Avail Clinical Research, LLC — DeLand
  • Clinical Pharmacology of Miami, LLC — Miami
  • Quotient Sciences — Miami
  • Advanced Pharma CR, LLC — Miami
  • Orlando Clinical Research Center — Orlando

Texas

  • Optimal Research, LLC — Austin
  • Worldwide Clinical Trials — San Antonio

California

  • Collaborative Neuroscience Network, LLC — Long Beach

Nevada

  • Clinical Research Consortium — Las Vegas

New Jersey

  • Hassman Research Institute — Berlin

Ohio

  • New Horizon Clinical Research — Cincinnati

Tennessee

  • New Orleans Center for Clinical Research — Knoxville

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2017-11-30
Est. Completion 2018-07-12
Phase Phase 1

Sponsor

Eagle Pharmaceuticals

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03324061

The ClinicalTrials.gov registry entry for NCT03324061 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eagle Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pharmacokinetics appearing as the primary indexed condition, and to 2 interventions — of which Fulvestrant for Injectable Suspension is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03324061 reports 12 study locations spanning 7 distinct geographic areas — top geographies include Florida, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03324061 about?

NCT03324061 is a clinical study titled "Study to Evaluate the Safety, Tolerability, and PK of Fulvestrant After IM Administration". 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.

What is the current status of trial NCT03324061?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 600 participants. The study started on 2017-11-30. Estimated completion is 2018-07-12.

What conditions does trial NCT03324061 study?

This clinical trial studies the following conditions: Pharmacokinetics. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03324061?

The interventions under investigation include: Fulvestrant for Injectable Suspension (DRUG), Faslodex (Reference) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03324061?

This trial is sponsored by Eagle Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03324061 being conducted?

This trial has 12 study locations across California, Florida, Nevada, New Jersey, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial