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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

NCT07043634 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-06

No results posted yet for this study

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.

Conditions

  • Bioavailability Heathy Volunteers

Interventions

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

Sponsors & Collaborators

  • Sarfez Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Salim Shah, PhD, JD · Sarfez Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-15
Primary Completion
2025-12-30
Completion
2025-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07043634 on ClinicalTrials.gov