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NCT03324061 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety, Tolerability, and PK of Fulvestrant After IM Administration
A Phase 1 study of Pharmacokinetics, sponsored by Eagle Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 600
- Enrollment target
- 12
- Study locations
NCT03324061 is a Phase 1 study of Pharmacokinetics that has completed, run by Eagle Pharmaceuticals. The registered enrollment target is 600 participants, above the 46-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (1204% higher). The trial reports 12 study locations across 7 states.
The verdict
NCT03324061, a Phase 1 study of Pharmacokinetics, has completed, sponsored by Eagle Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 600 participants
- Enrollment target
- 12
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2017-11-30 |
| Est. Completion | 2018-07-12 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 46-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (1204% higher). The listed sponsor is Eagle Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov.
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.
NCT03324061 reports 12 study locations spanning 7 distinct geographic areas - top geographies include Florida, Texas, California.
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.
What interventions are being tested in trial NCT03324061?
The interventions under investigation include: Fulvestrant for Injectable Suspension (DRUG), Faslodex (Reference) (DRUG).
Who is sponsoring clinical trial NCT03324061?
This trial is sponsored by Eagle Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.