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NCT07015671 · ClinicalTrials.gov registry record · Phase 3
Bioavailability and Bioequivalence Study of ER Torsemide and Spironolactone FDC Tablet in Healthy Subjects
A Phase 3 study, sponsored by Sarfez Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
NCT07015671: Completed Phase 3 study, sponsored by Sarfez Pharmaceuticals.
NCT07015671 is a Phase 3 study that has completed, run by Sarfez Pharmaceuticals. The registered enrollment target is 24 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07015671, a Phase 3 study, has completed, sponsored by Sarfez Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study examines the bioavailability and bioequivalence of single dose of a Fixed Dose Combination (FDC) tablet (12 mg Extended-Release Torsemide and 15mg Spironolactone). The goal of this study is to determine PK/PD effects of the FDC, 10 mg Torsemide alone, 25mg Aldactone® (Spironolactone) alone, and 10 mg Torsemide and 25 mg Aldactone® (Spironolactone) taken together in healthy subjects.
Primary Outcome
Compare bioequivalence and bioavailability (BE and BA) of the FDC to each of the components of the FDC, administered either individually or together: 10 mg Torsemide alone, 25 mg Spironolactone alone and 10 mg Torsemide and 25 mg Spironolactone taken together. Torsemide, Spironolactone, and Canrenone data will be used to estimate the following: Primary pharmacokinetic parameters: Cmax, AUC0-t and AUC0-inf.
Interventions
- DRUG 10 mg Torsemide tablet
- DRUG 25 mg Aldactone (Spironolactone) tablet
- DRUG FDC (12 mg ER Torsemide + 15mg Spironolactone) tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2025-12-30 |
| Phase | Phase 3 |
What the finished NCT07015671 record still lists
NCT07015671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which 10 mg Torsemide tablet is the first listed.
NCT07015671 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07015671 about?
NCT07015671 is a clinical study titled "Bioavailability and Bioequivalence Study of ER Torsemide and Spironolactone FDC Tablet in Healthy Subjects". This study examines the bioavailability and bioequivalence of single dose of a Fixed Dose Combination (FDC) tablet (12 mg Extended-Release Torsemide and 15mg Spironolactone). The goal of this study is to determine PK/PD effects of the FDC, 10 mg Torsemide alone, 25mg Aldactone® (Spironolactone) alon...
What is the current status of trial NCT07015671?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2025-07-01. Estimated completion is 2025-12-30.
What interventions are being tested in trial NCT07015671?
The interventions under investigation include: 10 mg Torsemide tablet (DRUG), 25 mg Aldactone (Spironolactone) tablet (DRUG), FDC (12 mg ER Torsemide + 15mg Spironolactone) tablet (DRUG).
Who is sponsoring clinical trial NCT07015671?
This trial is sponsored by Sarfez Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07015671's enrollment target sits among peer trials
24 1943rd of 2000 higher than 49 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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