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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: Completed Phase 1 study of Pharmacokinetics, sponsored by Eagle Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Area under the concentration-time curve(AUC)
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 |
What the finished NCT03324061 record still lists
NCT03324061 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 46-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (1204% higher).
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 lists 12 locations in 7 states (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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Where NCT03324061's enrollment target sits among peer trials
600 1st of 37 higher than 37 of 37 other Pharmacokinetics trials
participants (enrollment target), bucketed by value
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