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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 is a Phase 3 study that has completed, run by Sarfez Pharmaceuticals. The registered enrollment target is 24 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07015671
The ClinicalTrials.gov registry entry for NCT07015671 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sarfez Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which 10 mg Torsemide tablet is the first listed.
NCT07015671 reports 0 study locations.
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.
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