Food Effect on Torsemide + Spironolactone Bioavailability

Overseen By Chris Wilcox, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Sarfez Pharmaceuticals, Inc.

Must not be taking: Enzyme-modifying drugs

Disqualifiers: Cardiovascular, Pulmonary, Hepatic, Renal, 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: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination pill of extended-release Torsemide and Spironolactone to assess how food affects the drug's absorption. The goal is to determine whether taking the medication with or without food impacts its entry into the bloodstream. Participants should be healthy, non-smoking adults without recent significant health issues. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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 the study starts.

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

Research has shown that torsemide and spironolactone, often used together, are generally safe for people. The FDA has already approved these drugs for certain uses, indicating a basic level of safety. However, combining them into one pill might slightly alter their safety profile.

Previous studies have examined this combined pill, and results showed no unexpected side effects. Most people tolerate the treatment well, experiencing only mild side effects like dizziness or an upset stomach.

For those considering joining a trial for this treatment, it's important to know that these drugs have been used safely before. However, as with any medication, individual reactions can vary. Discuss potential risks with the study team or your doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the extended-release combination of torsemide and spironolactone because it offers a unique approach to enhancing bioavailability, especially when taken with food. Unlike standard diuretics and potassium-sparing agents, this fixed-dose combination aims to optimize the absorption and effectiveness of both medications, potentially resulting in improved management of conditions like heart failure or hypertension. By combining these two active ingredients in a single tablet, the treatment could simplify regimens for patients, reducing the number of pills taken daily and improving adherence to therapy.

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

Studies have shown that using torsemide and spironolactone together effectively manages fluid buildup in conditions like heart failure. Torsemide, a diuretic, helps the body eliminate excess salt and water, while spironolactone maintains balanced potassium levels. Together, these drugs enhance the body's ability to manage fluid and salt levels. Early research suggests that an extended-release combination allows steady absorption, leading to more consistent results. This trial will explore how food affects the absorption of the extended-release torsemide and spironolactone fixed-dose combination, with participants receiving the medication either with or without food. ^{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 who can safely take a combination of two medications, Torsemide and Spironolactone. Participants should not have any health conditions that could affect the drug's absorption or their safety during the study.

Inclusion Criteria

Willingness to provide written informed consent

Non-smokers and not consuming tobacco products

I am using two forms of birth control or am unable to have children.

Exclusion Criteria

Hypersensitivity or allergy to specific drugs or excipients

I have had problems with urination or controlling my bladder.

Recent blood donation, participation in another clinical study, or difficulty with blood sampling

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 days

Treatment Period 1

Participants receive a single dose of the FDC tablet without food

2 days

In-patient stay for dosing and sample collection

Washout

A washout period of at least 7 days between treatment periods

7 days

Treatment Period 2

Participants receive a single dose of the FDC tablet with food

2 days

In-patient stay for dosing and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 days

What Are the Treatments Tested in This Trial?

Interventions

• Extended Release Torsemide and Spironolactone Fixed Dose Combination

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. Participants will take the medication once with food and once without to compare results.

How Is the Trial Designed?

Group I: FDC (24 mg ER torsemide and 30 mg Spironolactone) tablet with food Active Control 2 Interventions

FDC (24 mg ER torsemide and 30 mg Spironolactone) tablet with food

Group II: FDC (24 mg ER torsemide and 30 mg Spironolactone) tablet without food Active Control 2 Interventions

FDC (24 mg ER torsemide and 30 mg Spironolactone) tablet without food

Who Is Running the Clinical Trial?

Sarfez Pharmaceuticals, Inc.

Lead Sponsor

Trials

6

Recruited

100+

Citations

1. 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 ...

2. 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 ...

3. 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.

4. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07046975

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

5. 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07223502

A Study Comparing the Clinical Benefit of Finerenone ... A study Comparing the Clinical Benefit of Finerenone Versus a Fixed-Dose Combination (FDC) of Extended-Release Torsemide and Spironolactone in ...

7. synapse.patsnap.com synapse.patsnap.com/drug/4378069521274473be82c7c6196fe671

Spironolactone - Drug Targets, Indications, Patents ... Effect of Food on the Bioavailability of Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) Tablet in Healthy Adult Human Subjects.