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NCT04446507 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of Saroglitazar Magnesium in Subjects with Severe Renal Impairment and Normal Renal Function
A Phase 1 study, sponsored by Zydus Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT04446507: Completed Phase 1 study, sponsored by Zydus Therapeutics.
NCT04446507 is a Phase 1 study that has completed, run by Zydus Therapeutics. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04446507, a Phase 1 study, has completed, sponsored by Zydus Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This will be a Phase 1, Open-label Study of Participants with Normal Renal Function and Participants with Sever Renal Impairment.
Primary Outcome
The area under the plasma concentration versus time curve from zero to infinity will be calculated by adding Ct/Kel to AUCt, where Ct is the last quantifiable concentration and Kel is the elimination rate constant.
Interventions
- DRUG Saroglitazar magnesium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-07-27 |
| Est. Completion | 2024-05-28 |
| Phase | Phase 1 |
What the finished NCT04446507 record still lists
NCT04446507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which Saroglitazar magnesium is the first listed.
NCT04446507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04446507 about?
NCT04446507 is a clinical study titled "A Pharmacokinetic Study of Saroglitazar Magnesium in Subjects with Severe Renal Impairment and Normal Renal Function". This will be a Phase 1, Open-label Study of Participants with Normal Renal Function and Participants with Sever Renal Impairment.
What is the current status of trial NCT04446507?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2020-07-27. Estimated completion is 2024-05-28.
What interventions are being tested in trial NCT04446507?
The interventions under investigation include: Saroglitazar magnesium (DRUG).
Who is sponsoring clinical trial NCT04446507?
This trial is sponsored by Zydus Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04446507's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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