ER Torsemide + Spironolactone for Bioequivalence 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, 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: 289

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the absorption of a combination tablet of two drugs, Torsemide and Spironolactone, with taking each drug separately. The focus is on understanding how these drugs interact in healthy individuals. Suitable candidates for this trial are healthy non-smokers without significant medical issues or drug allergies, particularly to Torsemide or Spironolactone. As a Phase 3 trial, this study is the final step before FDA approval, allowing participants to contribute to the potential availability of a new 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?

Previous studies have shown that treatments like Torsemide and Spironolactone are generally well-tolerated. Torsemide, an FDA-approved diuretic, helps the body eliminate excess water and salt and has been safely used for fluid retention and high blood pressure. Research indicates that Torsemide's side effects are usually mild, such as dizziness or headaches.

Spironolactone, also FDA-approved, is often used to treat heart failure and high blood pressure. Studies report that Spironolactone can cause side effects like elevated potassium levels or stomach upset, but these are usually manageable with medical supervision.

The new combination of these two drugs in one tablet is currently being tested to assess how the body handles it. While this specific combination remains under study, the individual drugs have a history of safe use when taken separately. The ongoing study aims to confirm that using them together is also safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer a new approach to managing fluid retention and high blood pressure by combining torsemide and spironolactone in novel ways. Unlike standard treatments that often involve separate dosing, the study includes a fixed-dose combination (FDC) tablet, which simplifies administration by combining extended-release torsemide with spironolactone in a single pill. This approach not only improves patient convenience but also ensures consistent drug delivery, potentially enhancing effectiveness and reducing side effects. Additionally, the simultaneous administration of these medications could enhance their synergistic effects, offering a more comprehensive treatment option for conditions like heart failure and hypertension.

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

Research has shown that both torsemide and spironolactone effectively treat certain health conditions. Spironolactone lowers blood pressure in individuals with primary hyperaldosteronism. Torsemide, a diuretic, helps the body eliminate excess fluid and is often used for heart-related issues. In this trial, participants may receive torsemide, spironolactone, or a combination of both. Studies have found that using these two medicines together can enhance each other's benefits. Early research suggests that the combination tablet of extended-release torsemide and spironolactone, tested in this trial, is well absorbed by the body. This combination could offer a convenient and effective treatment option. ^{1 3 5 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 clinical trial is for healthy individuals who can participate in a study to compare the effects and absorption of different blood pressure medications taken alone or combined. Specific eligibility criteria are not provided, but typically participants must be adults without any significant health issues.

Inclusion Criteria

I am using two forms of birth control during the study.

Willingness to provide written informed consent

Literate subjects

Exclusion Criteria

Positive pregnancy tests or lactating females

Positive screening results for specific infections

Positive results in alcohol or drug screening tests

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment Period 1

Participants receive Treatment A: 10 mg Torsemide tablet

3 days

In-facility stay for at least 72 hours post-dose

Washout

A washout period between treatment periods

7 days

Treatment Period 2

Participants receive Treatment B: 25 mg Aldactone (Spironolactone) tablet

3 days

In-facility stay for at least 72 hours post-dose

Washout

A washout period between treatment periods

7 days

Treatment Period 3

Participants receive Treatment C: FDC (12 mg ER Torsemide + 15 mg Spironolactone) tablet

3 days

In-facility stay for at least 72 hours post-dose

Washout

A washout period between treatment periods

7 days

Treatment Period 4

Participants receive Treatment D: 10 mg Torsemide tablet and 25 mg Aldactone® (Spironolactone) tablet given together

3 days

In-facility stay for at least 72 hours post-dose

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spironolactone
• Torsemide

Trial Overview

The study tests how well the body absorbs a combination tablet containing Extended-Release Torsemide and Spironolactone (FDC) compared to taking each drug separately. It measures the pharmacokinetics (PK) and pharmacodynamics (PD) effects in healthy subjects after a single dose.

How Is the Trial Designed?

Group I: Treatment D Experimental Treatment 2 Interventions

10 mg Torsemide tablet and 25 mg Aldactone® (Spironolactone) tablet given together

Group II: Treatment C Experimental Treatment 1 Intervention

FDC (12 mg ER Torsemide + 15 mg Spironolactone) tablet

Group III: Treatment B Experimental Treatment 1 Intervention

25 mg Aldactone (Spironolactone) tablet

Group IV: Treatment A Experimental Treatment 1 Intervention

10 mg Torsemide tablet

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.

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.

3.

withpower.com

withpower.com/trial/phase-3-bioequivalence-study-in-healthy-subjects-6-2025-f552f

ER Torsemide + Spironolactone for Bioequivalence Study

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

4.

adisinsight.springer.com

adisinsight.springer.com/trials/700383543

Bioavailability and Bioequivalence (BA/BE) Study of Extended ...

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

5.

sigma.larvol.com

sigma.larvol.com/company.php?e1=766920&tab=OTTtrac&sourcepg=TZC

Sarfez Pharma Trials

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 ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07015671?term=AREA%5BBasicSearch%5D(Spironolactone)&rank=10

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 ...

7.

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 ...