Clinical Trial

Bioavailability and Bioequivalence Study of ER Torsemide and Spironolactone FDC Tablet in Healthy Subjects

Completed Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-06-03; most recent amendment 2026-03-05.
Status change: Recruiting → Completed 2026-03-05
Trial Details
NCT Number NCT07015671
Lead Sponsor Sarfez Pharmaceuticals, Inc.
Conditions Bioequivalence Study in Healthy Subjects, PK/PD
Enrollment 24 participants
Start Date 2025-07-01
Primary Completion 2025-12-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-06