Study to Evaluate the Safety, Tolerability, and PK of Fulvestrant After IM Administration
Public ClinicalTrials.gov record NCT03324061. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Fulvestrant (Test vs. Reference) Following Intramuscular Administration to the Gluteal Muscle in Healthy Female Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03324061
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 600 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 75 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2017 (Actual)
- Primary completion
- Jul 12, 2018 (Actual)
- Completion
- Jul 12, 2018 (Actual)
- Last update posted
- Jun 3, 2021
2017 – 2018
United States locations
- U.S. sites
- 12
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Collaborative Neuroscience Network, LLC | Long Beach | California | 90806 | — |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | — |
| Clinical Pharmacology of Miami, LLC | Miami | Florida | 33014 | — |
| Quotient Sciences | Miami | Florida | 33126 | — |
| Advanced Pharma CR, LLC | Miami | Florida | 33147 | — |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | — |
| Clinical Research Consortium | Las Vegas | Nevada | 89119 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| New Horizon Clinical Research | Cincinnati | Ohio | 45242 | — |
| New Orleans Center for Clinical Research | Knoxville | Tennessee | 37920 | — |
| Optimal Research, LLC | Austin | Texas | 78705 | — |
| Worldwide Clinical Trials | San Antonio | Texas | 78217 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03324061, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 3, 2021 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03324061 live on ClinicalTrials.gov.