Recruiting

Extended Release Torsemide-Spironolactone Fixed Dose Combination Tablet Bioequivalence Study in Healthy Adults

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Study AimThis study aims to compare the extended release Torsemide-Spironolactone fixed dose combination tablet to a regular version in healthy adults by analyzing blood and urine samples to evaluate how the body processes and excretes the medication.
What is being tested

Torsemide and Spironolactone tablet

+ Torsemide Tablets and Spironolactone Tablets
Drug
Who is being recruted

Bioavailability Heathy Volunteers

From 18 to 45 Years
+36 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 2025

See protocol details

Summary

Principal SponsorSarfez Pharmaceuticals, Inc.
Study ContactChris Wilcox, MD, PhD
Last updated: July 2, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: June 15, 2025Actual date on which the first participant was enrolled.

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. It specifically focuses on understanding how these drugs are absorbed and processed over multiple doses in healthy adults. The research is important because it helps determine if this combination is consistently effective and safe, which could potentially offer a more convenient treatment option for patients who need both medications. Participants in the study will take the Extended Release Torsemide and Spironolactone combination tablet, as well as separate tablets of Torsemide and Aldactone (another form of Spironolactone). The study monitors how these drugs affect the body by measuring levels of Torsemide and certain elements like sodium, potassium, and creatinine in urine samples. These measurements help researchers understand the drugs' effects and how they might work in a steady state, ensuring that the treatment is both effective and safe over time.

Official TitleBioavailability and Bioequivalence (BA/BE) Study of Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) Tablet in Healthy Adult Human Subjects 
Principal SponsorSarfez Pharmaceuticals, Inc.
Study ContactChris Wilcox, MD, PhD
Last updated: July 2, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
24 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 45 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bioavailability Heathy Volunteers
Criteria
10 inclusion criteria required to participate
ubjects must fulfill all of the following criteria to be considered for inclusion into this study
Healthy human adult subjects within the age range of 18 to 45 years \[both inclusive\]
Weight not less than 50 kg for male and 45 kg for female and BMI 18.50 to 29.99 kg/m2 \[both inclusive\]
Willingness to provide written informed consent to participate in the study

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26 exclusion criteria prevent from participating
ny of the following conditions are cause for exclusion from the study
History or presence of significant: cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, musculoskeletal, psychiatric disease/disorder
History or presence of significance
sthma, urticaria, or other allergic-type reactions after taking Torsemide, Spironolactone or any other drug

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Active Comparator
Fixed Dose Combination (FDC) 12 mg ER Torsemide and 15 mg Spironolactone tablet
Group II
Active Comparator
10 mg Torsemide and 25 mg Spironolactone tablets given together
Study Objectives
Primary Objectives

Measurement of torsemide in the blood for Cmax.

Measurement of torsemide in the blood for AUC.

Measurement of Spironolactone and Canrenone in the blood (Active metabolite of spironolactone) for Cmax.

Measurement of Spironolactone and Canrenone (Active metabolite of spironolactone) for AUC.

Urine samples will be used to calculate urinary excretion at each timepoint and the total in 24 hours.

Calculate percentage of torsemide recovered in the urine.

Urinary torsemide excretion will be measured for Rmax.

Electrolytes (sodium, potassium) will be measured to determine the percentage of drug recovered.

Urinary creatinine will be measured at each timepoint over 24 hours.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Sarfez PharmaceuticalsVienna, United StatesSee the location
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One Study Center