NCT07043634

A Study to Evaluate the Effect of Food or no Food on the Bioavailability of an Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) Tablet in Healthy Adult Subjects

An Open Label, Randomized, Two-period, Two-sequence, Balanced, Single Dose Crossover Study to Evaluate the Effect of Food on the Bioavailability 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

This study will examine comparative bioavailability of single dose of a fixed dose combination (FDC) of extended release Torsemide and Spironolactone given with or without food in healthy adult subjects.

Detailed description

To study comparative bioavailability (BA) of single dose of the FDC (24 mg ER Torsemide and 30 mg Spironolactone) tablet given with or without food in healthy adult subjects. The total expected study duration is at least 11 days from the day of check-in for Period 1 to the end of Period 2. There will be a washout period of at least 07 days will be maintained in between the periods. Treatment will be as follows: (A): Fixed dose combination (FDC) of 24 mg ER Torsemide + 30 mg Spironolactone tablet without food. Dose: 1x (24 mg +30 mg) FDC tablet Treatment (B): FDC (24 mg ER Torsemide + 30 mg Spironolactone) tablet with food. Dose: 1x (24 mg +30 mg) FDC tablet Route of Administration for both treatments: Oral

Conditions

• Bioavailability Heathy Volunteers

Interventions

Type	Name	Description
COMBINATION_PRODUCT	FDC (24 mg ER torsemide and 30 mg Spironolactone) without food	FDC without food
COMBINATION_PRODUCT	FDC (24 mg ER torsemide and 30 mg Spironolactone) with food	FDC with food

Timeline

• Start date: 2025-06-15
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2025-06-29
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study