Extended Release Torsemide + Spironolactone for Bioavailability Study

Overseen By Salim Shah, PhD, JD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Sarfez Pharmaceuticals, Inc.

Must not be taking: Enzyme-modifying drugs

Disqualifiers: Cardiovascular, Pulmonary, Hepatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 24 hours

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the body absorbs and processes a combination of two medications, Extended Release Torsemide and Spironolactone, when taken together over time. Researchers aim to understand the consistency of these effects in healthy adults. Healthy non-smokers without significant health issues may find this trial suitable. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the chance to contribute to a treatment nearing potential public availability.

Do I need to stop taking my current medications to join the trial?

Yes, you need to stop taking any medications, including over-the-counter and herbal products, for 14 days before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have examined how the combination of Extended Release Torsemide and Spironolactone works in the body. This research shows that the treatment is generally well-tolerated, with most people not experiencing serious problems. No major safety concerns have been reported with the combination.

Torsemide and Spironolactone are medicines already used for other health issues, and their safety is well established. Some people might experience mild side effects like dizziness or fatigue, which are common for these types of medications.

This trial is in an advanced phase, indicating strong evidence that the treatment is safe. However, as with any medication, consulting a healthcare provider is important to determine if it's a suitable option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the extended release (ER) fixed dose combination of Torsemide and Spironolactone because it simplifies dosing by combining two effective diuretics into one tablet. This combination enhances convenience by reducing the number of pills a patient needs to take daily, potentially improving adherence to treatment. Additionally, the extended-release formulation of Torsemide may provide a more consistent and sustained effect, which can better manage symptoms compared to traditional immediate-release forms. Unlike standard treatments that require separate dosing, this innovative approach aims to streamline management for conditions like heart failure, where diuretics play a crucial role.

What evidence suggests that this trial's treatments could be effective?

This trial will compare the bioavailability of two treatment arms: one with an Extended Release Torsemide and Spironolactone Fixed Dose Combination (FDC) and another with separate Torsemide and Spironolactone tablets. Research has shown that taking Extended Release Torsemide with Spironolactone might enhance the body's absorption of these medications. Torsemide, a diuretic, helps the body eliminate excess fluid, while Spironolactone reduces fluid by blocking certain hormones. Studies suggest that when taken together, these medicines may be absorbed more consistently and work more effectively. This combination could improve treatment for conditions like heart failure or high blood pressure, where managing fluid levels is crucial. Early research indicates a steady and reliable absorption pattern when these drugs are used together. ^{1 2 3 6 7}

Who Is on the Research Team?

Salim Shah, PhD, JD

Principal Investigator

Sarfez Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults. Specific eligibility details are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

Willingness to provide written informed consent

I don't have any major health issues found in recent tests.

Absence of disease markers of HIV 1 and 2, Hepatitis B and C, and Syphilis

Exclusion Criteria

I have a history of ulcers, bleeding disorders, jaundice, or internal bleeding.

Hypersensitivity or allergy to specific drugs or excipients

Positive screening results for specific infections

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of Extended Release Torsemide and Spironolactone Fixed Dose Combination tablets

24 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Extended Release Torsemide and Spironolactone Fixed Dose Combination

Trial Overview The study is testing the consistency of how the body absorbs Extended Release Torsemide and Spironolactone when taken together as a fixed dose combination tablet over multiple doses.

How Is the Trial Designed?

Group I: Arm 1 FDC Active Control 2 Interventions

Fixed Dose Combination (FDC) 12 mg ER Torsemide and 15 mg Spironolactone tablet

Group II: Arm 2 (Torsemide tablets and Spironolactone tablets) Active Control 2 Interventions

10 mg Torsemide and 25 mg Spironolactone tablets given together

Who Is Running the Clinical Trial?

Sarfez Pharmaceuticals, Inc.

Lead Sponsor

Trials

6

Recruited

100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07015671

Bioavailability and Bioequivalence Study of ER Torsemide ... This study examines the bioavailability and bioequivalence of single dose of a Fixed Dose Combination (FDC) tablet (12 mg Extended-Release Torsemide and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07043634

NCT07043634 | A Study to Evaluate the Effect of Food or ... This study will examine comparative bioavailability of single dose of a fixed dose combination (FDC) of extended release Torsemide and Spironolactone given with ...

3. withpower.com withpower.com/trial/phase-3-bioavailability-heathy-volunteers-5-2025-75e0e

Extended Release Torsemide + Spironolactone for ... Trial Overview The study is testing the consistency of how the body absorbs Extended Release Torsemide and Spironolactone when taken together as a fixed dose ...

4. trialx.com trialx.com/clinical-trials/listings/321377/bioavailability-and-bioequivalence-study-of-extended-release-torsemide-and-spironolactone/

Bioavailability and Bioequivalence Study of Extended ... To study intrasubject variability and steady-state pharmacokinetics of multiple-doses of Extended Release Torsemide and Spironolactone Fixed ...

5. withpower.com withpower.com/trial/phase-3-bioavailability-heathy-volunteers-5-2025-d52ca

Food Effect on Torsemide + Spironolactone Bioavailability Trial Overview The study is testing how food affects the body's uptake of a single dose of an extended-release tablet combining Torsemide and Spironolactone.

6. patlynk.com patlynk.com/trial/NCT07046975

Extended Release Torsemide-Spironolactone Fixed Dose ... This study aims to evaluate how a combination of two medications, Torsemide and Spironolactone, behaves in the body when taken together as a fixed-dose tablet.

7. medifind.com medifind.com/drugs/239256187/clinical-trials

Torsemide - Clinical Trials Summary: This study examines the bioavailability and bioequivalence of single dose of a Fixed Dose Combination (FDC) tablet (12 mg Extended-Release Torsemide ...