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NCT04112446 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Absorption, Metabolism and Excretion of Single-dose [14C]-Saroglitazar in Healthy Male Subjects
A Phase 1 study, sponsored by Zydus Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT04112446: Completed Phase 1 study, sponsored by Zydus Therapeutics.
NCT04112446 is a Phase 1 study that has completed, run by Zydus Therapeutics. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04112446, a Phase 1 study, has completed, sponsored by Zydus Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This will be a Phase I, open-label, nonrandomized, single-dose study in healthy male subjects.
Primary Outcome
Area under the time curve from time zero to infinity will be calculated for saroglitazar and saroglitazar sulfoxide in plasma, and total radioactivity in whole blood and plasma
Interventions
- DRUG Saroglitazar magnesium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-09-20 |
| Est. Completion | 2019-10-29 |
| Phase | Phase 1 |
What the finished NCT04112446 record still lists
NCT04112446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Saroglitazar magnesium is the first listed.
NCT04112446 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04112446 about?
NCT04112446 is a clinical study titled "Study to Evaluate Absorption, Metabolism and Excretion of Single-dose [14C]-Saroglitazar in Healthy Male Subjects". This will be a Phase I, open-label, nonrandomized, single-dose study in healthy male subjects.
What is the current status of trial NCT04112446?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2019-09-20. Estimated completion is 2019-10-29.
What interventions are being tested in trial NCT04112446?
The interventions under investigation include: Saroglitazar magnesium (DRUG).
Who is sponsoring clinical trial NCT04112446?
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 NCT04112446's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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