NCT07046975

Bioavailability and Bioequivalence Study of Extended Release Torsemide and Spironolactone

Bioavailability and Bioequivalence (BA/BE) Study of Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) Tablet in Healthy Adult Human Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sarfez Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To study intrasubject variability and steady-state pharmacokinetics of multiple-doses of Extended Release Torsemide and Spironolactone Fixed Dose Combination (FDC) tablets given together in healthy adult subjects.

Detailed description

To study intrasubject variability and steady-state pharmacokinetics of the multiple-doses of Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) (12 mg ER Torsemide and 15 mg Spironolactone) tablet and 10 mg Torsemide and 25 mg Aldactone® (Spironolactone) tablets given together in healthy adult subjects. In addition, torsemide, sodium, potassium, and creatinine will be measured in the urine samples.

Conditions

• Bioavailability Heathy Volunteers

Interventions

Type	Name	Description
DRUG	Torsemide and Spironolactone tablet	Fixed Dose Combination (FDC): (12 mg Extended Release (ER) Torsemide and 15 mg Spironolactone) tablet
DRUG	Torsemide Tablets and Spironolactone Tablets	10 mg Torsemide tablet and 25 mg Spironolactone tablet given together

Timeline

• Start date: 2025-06-15
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2025-07-02
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study