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Bioavailability and Bioequivalence Study of Extended Release Torsemide and Spironolactone

NCT07046975 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-09

No results posted yet for this study

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.

Conditions

  • Bioavailability Heathy Volunteers

Interventions

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

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
2026-02-28
Completion
2026-02-28
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 NCT07046975 on ClinicalTrials.gov