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NCT04155814 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study Assessing Iron Sucrose or Venofer® in Healthy Adult Subjects
A Phase 1 study, sponsored by Baxter Healthcare Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 196
- Enrollment target
NCT04155814: Completed Phase 1 study, sponsored by Baxter Healthcare Corporation.
NCT04155814 is a Phase 1 study that has completed, run by Baxter Healthcare Corporation. The registered enrollment target is 196 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (227% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04155814, a Phase 1 study, has completed, sponsored by Baxter Healthcare Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 196 participants
- Enrollment target
Study Summary
This study evaluates the bioequivalence, pharmacokinetic (PK) profile, and safety and tolerability of Iron Sucrose (Test Product) relative to that of Venofer® in healthy subjects.
Primary Outcome
Maximum concentration (Cmax) across all time points for the delta difference between Total Iron (TI) and Transferrin Bound Iron (TBI). This is a PK test parameter to compare bioequivalence of two drug products.
Interventions
- DRUG Iron Sucrose Injection
- DRUG Venofer Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2019-09-19 |
| Est. Completion | 2019-12-18 |
| Phase | Phase 1 |
What the finished NCT04155814 record still lists
NCT04155814 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (227% higher).
The record links to 0 conditions, and to 2 interventions - of which Iron Sucrose Injection is the first listed.
NCT04155814 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04155814 about?
NCT04155814 is a clinical study titled "Bioequivalence Study Assessing Iron Sucrose or Venofer® in Healthy Adult Subjects". This study evaluates the bioequivalence, pharmacokinetic (PK) profile, and safety and tolerability of Iron Sucrose (Test Product) relative to that of Venofer® in healthy subjects.
What is the current status of trial NCT04155814?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 196 participants. The study started on 2019-09-19. Estimated completion is 2019-12-18.
What interventions are being tested in trial NCT04155814?
The interventions under investigation include: Iron Sucrose Injection (DRUG), Venofer Injection (DRUG).
Who is sponsoring clinical trial NCT04155814?
This trial is sponsored by Baxter Healthcare Corporation, which has 46 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04155814's enrollment target sits among peer trials
196 279th of 2000 higher than 1,720 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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