ER Torsemide + Spironolactone for Bioequivalence Study
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.12345Why 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.13567
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive Treatment A: 10 mg Torsemide tablet
Washout
A washout period between treatment periods
Treatment Period 2
Participants receive Treatment B: 25 mg Aldactone (Spironolactone) tablet
Washout
A washout period between treatment periods
Treatment Period 3
Participants receive Treatment C: FDC (12 mg ER Torsemide + 15 mg Spironolactone) tablet
Washout
A washout period between treatment periods
Treatment Period 4
Participants receive Treatment D: 10 mg Torsemide tablet and 25 mg Aldactone® (Spironolactone) tablet given together
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Spironolactone
- Torsemide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sarfez Pharmaceuticals, Inc.
Lead Sponsor