Bioequivalence Study in Healthy SubjectsPhase 3NCT07015671
Bioavailability and Bioequivalence Study of ER Torsemide and Spironolactone FDC Tablet in Healthy Subjects
A Phase 3 study testing 10 mg Torsemide tablet, 25 mg Aldactone (Spironolactone) tablet and FDC (12 mg ER Torsemide + 15mg Spironolactone) tablet in people with Bioequivalence Study in Healthy Subjects and PK/PD, run by Sarfez Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study examines the bioavailability and bioequivalence of single dose of a Fixed Dose Combination (FDC) tablet (12 mg Extended-Release Torsemide and 15mg Spironolactone). The goal of this study is to determine PK/PD effects of the FDC, 10 mg Torsemide alone, 25mg Aldactone® (Spironolactone) alone, and 10 mg… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence Study in Healthy Subjects, PK/PD
- What is being tested?
- 10 mg Torsemide tablet, 25 mg Aldactone (Spironolactone) tablet and FDC (12 mg ER Torsemide + 15mg Spironolactone) tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 30 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects 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.
- Subjects should be non-smoker [defined as someone who has stopped smoking for a year before the date of screening] and should not be consuming tobacco containing products.
- Free of significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG, Chest X-ray [PA view].
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- Absence of disease markers of HIV 1 and 2, Hepatitis B and C and Syphilis.
- Subject should be literate.
- Male subjects must be using two acceptable methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and upto the study completion visit. Subjects must refrain from fathering a child in the next two weeks following the last study drug administration or have undergone vasectomy (vasectomy must have been done more than 6 months prior to first dosing). Contraceptive usage requirement will be conveyed during the inform consent process. Subjects will be advised to follow effective method of contraception until 2 weeks after the last dose is given.
- Female subjects of childbearing potential must be using two acceptable methods of contraception, (e.g., intra-uterine device (IUD) plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the study and for two weeks following the last study drug administration. Contraceptive usage requirement will be conveyed during the inform consent process (or) Postmenopausal women for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy have been performed).
Who cannot join
- Any 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:
- Asthma, urticaria, or other allergic-type reactions after taking Torsemide, Spironolactone or any other drug. Ulceration or history of gastric and/or duodenal ulcer. Stomach or intestinal bleeding. Jaundice in the past 6 months. Internal bleeding.
- Hypersensitivity or allergy to Torsemide, Spironolactone or any of the excipients.
- History of alcohol or drug abuse in the past one year.
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- Family history of bleeding disorders.
- History of difficulty in passing urine or emptying the bladder or of incontinence.
- Have donated 500 mL or more blood within 90 days before receiving the first dose of the study drug.
- Subjects who have participated in another clinical study in the past 3 months prior to commencement of this study.
- Any difficulty in the accessibility of forearm veins for cannulation or blood sampling and or difficulty with donating blood.
- Refuse to abstain from food for at least 10 h prior to dosing and for at least 4 h after dosing in each period.
- Refuse to abstain from fluid for at least 1 h before and 1 h after dosing in each period (except 240 ± 2 mL water given for dosing).
- Found positive during breath alcohol test done during period one check-in and inability to abstain from alcohol till the end of the study.
- Found positive during urine drug screening done prior to period one check-in.
- Found positive screening results for Hepatitis B, Hepatitis C, HIV, or Syphilis.
- History of difficulty in swallowing tablets.
- Received any medication [including over-the-counter products], herbal products for 14days preceding the study.
- Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
- History of dehydration from diarrhea, vomiting, or any other reason within 24 hours prior to check-in of period one.
- Consumption of xanthine-containing food and beverages (chocolates, tea, coffee, or cola drinks) for at least 48 hours prior to check-in of period one.
- Consumption of grapefruit or its products within the 48 hours prior to check-in of period one.
- Female subjects are found to be positive during pregnancy tests done prior to period one check-in.
- Lactating females.
- Investigator/Physician feels that it is not in the subject's and/or study's best interest to enroll the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioavailability and Bioequivalence (BA/BE) Study of Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) Tablet in Healthy Subjects
This study examines the bioavailability and bioequivalence of single dose of a Fixed Dose Combination (FDC) tablet (12 mg Extended-Release Torsemide and 15mg Spironolactone). The goal of this study is to determine PK/PD effects of the FDC, 10 mg Torsemide alone, 25mg Aldactone® (Spironolactone) alone, and 10 mg Torsemide and 25 mg Aldactone® (Spironolactone) taken together in healthy subjects.
Read the detailed description
Screening and Study Assessments Demographic data, medical, surgical and medication histories, physical examination, height, weight and BMI as well as 12 lead ECG, chest X-ray [PA view], vital signs [blood pressure, pulse rate, respiratory rate and oral temperature], Oxygen Saturation (SpO2 %), hematology, biochemistry, HIV 1 \& 2, Hepatitis B and C, RPR test for Syphilis and urinalysis will be done at screening. Females will undergo a serum pregnancy test at the time of screening.
Urine drug screen and breath alcohol test will be done prior to each check-in. Urine pregnancy test will be performed for females prior to each check-in.
Study Duration The total expected study duration is at least 27 days from the day of check-in for Period 1 to the end of Period 4. In case of any post-study laboratory parameter abnormalities, the subject will be followed up at the investigator's discretion.
Washout Period A washout period of at least 07 days will be maintained in between the periods.
Housing Subjects will be housed in the facility from at least 36 hours prior to day of dosing until at least 72 hours post-dose in each period.
Treatments
Treatments Administered:
Treatment (A): 10 mg Torsemide tablet Dose: 1x 10 mg tablet Route of Administration: Oral
Treatment (B): 25 mg Aldactone® (Spironolactone) tablet Dose: 1x 25 mg tablet Route of Administration: Oral
Treatment (C): FDC (12 mg ER Torsemide + 15 mg Spironolactone) tablet. Dose: 1x (12 mg + 15 mg) FDC tablet Route of Administration: Oral
Treatment (D): 10 mg Torsemide tablet and 25 mg Aldactone® (Spironolactone) tablet given together Dose: 1x 10 mg Torsemide tablet + 1x 25 mg Spironolactone tablet Route of Administration: Oral
Blood and Urine Sampling
All subjects will be given a labeled container for urine collection in each period.
Blood samples will be collected in each period.
Adverse and serious adverse events will be monitored throughout the study.
- Conditions
- Bioequivalence Study in Healthy Subjects, PK/PD
- Being tested
- 10 mg Torsemide tablet, 25 mg Aldactone (Spironolactone) tablet, FDC (12 mg ER Torsemide + 15mg Spironolactone) tablet
- Keywords
- torsemide, Spironolactone, bioequivalence, diuresis, extended release, immediate release, PK/PD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mg Torsemide tabletDrug
Single dose 10 mg Torsemide tablet
25 mg Aldactone (Spironolactone) tabletDrug
Single dose 25 mg Aldactone® (Spironolactone) tablet
FDC (12 mg ER Torsemide + 15mg Spironolactone) tabletDrug
Single dose FDC (12 mg ER Torsemide + 15 mg Spironolactone) tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | 10 mg Torsemide tablet Receives: Drug: 10 mg Torsemide tablet |
| Treatment B | Experimental | 25 mg Aldactone (Spironolactone) tablet Receives: Drug: 25 mg Aldactone (Spironolactone) tablet |
| Treatment C | Experimental | FDC (12 mg ER Torsemide + 15 mg Spironolactone) tablet Receives: Drug: FDC (12 mg ER Torsemide + 15mg Spironolactone) tablet |
| Treatment D | Experimental | 10 mg Torsemide tablet and 25 mg Aldactone® (Spironolactone) tablet given together Receives: Drug: 10 mg Torsemide tablet; Drug: 25 mg Aldactone (Spironolactone) tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence and bioavailability of the FDC to each of its components
Compare bioequivalence and bioavailability (BE and BA) of the FDC to each of the components of the FDC, administered either individually or together: 10 mg Torsemide alone, 25 mg Spironolactone alone and 10 mg Torsemide and 25 mg Spironolactone taken together. Torsemide, Spironolactone, and Canrenone data will be used to estimate the following: Primary pharmacokinetic parameters: Cmax, AUC0-t and AUC0-inf.
Measured: Through study completion: at least 27 days with minimum 7 days washout periods between testing
Urinary torsemide excretion
Urinary torsemide excretion: Rmax, Ae0-24, tmax and percentage drug recovered.
Measured: Through study completion: at least 27 days with minimum 7 days washout periods between testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jul 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence Study in Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open label, randomized, four period, four sequence, balanced, single dose, crossover BA/BE study of the fixed dose combination (FDC) and its components administered individually or together, under fasting conditions.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarfez Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Salim Shah, PhD, JD, Study chair, Sarfez Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015671
- Sponsor's protocol ID
- SAR-HS-025-23
- Status last verified
- Mar 2026
- First submitted
- 3 Jun 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability and Bioequivalence (BA/BE) Study of Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) Tablet in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07015671
- Acronym / sponsor ID
- SAR-HS-025-23
- Conditions
- Bioequivalence Study in Healthy Subjects, PK/PD
- Keywords
- torsemide, Spironolactone, bioequivalence, diuresis, extended release, immediate release, PK/PD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sarfez Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the bioavailability and bioequivalence of single dose of a Fixed Dose Combination (FDC) tablet (12 mg Extended-Release Torsemide and 15mg Spironolactone). The goal of this study is to determine PK/PD effects of the FDC, 10 mg Torsemide alone, 25mg Aldactone® (Spironolactone) alone, and 10 mg Torsemide and 25 mg Aldactone® (Spironolactone) taken together in healthy subjects.
Detailed description
Screening and Study Assessments Demographic data, medical, surgical and medication histories, physical examination, height, weight and BMI as well as 12 lead ECG, chest X-ray [PA view], vital signs [blood pressure, pulse rate, respiratory rate and oral temperature], Oxygen Saturation (SpO2 %), hematology, biochemistry, HIV 1 \& 2, Hepatitis B and C, RPR test for Syphilis and urinalysis will be done at screening. Females will undergo a serum pregnancy test at the time of screening.
Urine drug screen and breath alcohol test will be done prior to each check-in. Urine pregnancy test will be performed for females prior to each check-in.
Study Duration The total expected study duration is at least 27 days from the day of check-in for Period 1 to the end of Period 4. In case of any post-study laboratory parameter abnormalities, the subject will be followed up at the investigator's discretion.
Washout Period A washout period of at least 07 days will be maintained in between the periods.
Housing Subjects will be housed in the facility from at least 36 hours prior to day of dosing until at least 72 hours post-dose in each period.
Treatments
Treatments Administered:
Treatment (A): 10 mg Torsemide tablet Dose: 1x 10 mg tablet Route of Administration: Oral
Treatment (B): 25 mg Aldactone® (Spironolactone) tablet Dose: 1x 25 mg tablet Route of Administration: Oral
Treatment (C): FDC (12 mg ER Torsemide + 15 mg Spironolactone) tablet. Dose: 1x (12 mg + 15 mg) FDC tablet Route of Administration: Oral
Treatment (D): 10 mg Torsemide tablet and 25 mg Aldactone® (Spironolactone) tablet given together Dose: 1x 10 mg Torsemide tablet + 1x 25 mg Spironolactone tablet Route of Administration: Oral
Blood and Urine Sampling
All subjects will be given a labeled container for urine collection in each period.
Blood samples will be collected in each period.
Adverse and serious adverse events will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Open label, randomized, four period, four sequence, balanced, single dose, crossover BA/BE study of the fixed dose combination (FDC) and its components administered individually or together, under fasting conditions.
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: 10 mg Torsemide tablet10 mg Torsemide tablet |
| Treatment B | Experimental | Drug: 25 mg Aldactone (Spironolactone) tablet25 mg Aldactone (Spironolactone) tablet |
| Treatment C | Experimental | Drug: FDC (12 mg ER Torsemide + 15mg Spironolactone) tabletFDC (12 mg ER Torsemide + 15 mg Spironolactone) tablet |
| Treatment D | Experimental | Drug: 10 mg Torsemide tablet, Drug: 25 mg Aldactone (Spironolactone) tablet10 mg Torsemide tablet and 25 mg Aldactone® (Spironolactone) tablet given together |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subjects 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.
- Subjects should be non-smoker [defined as someone who has stopped smoking for a year before the date of screening] and should not be consuming tobacco containing products.
Key exclusion criteria (25 listed)
- History or presence of significant: cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, musculoskeletal, psychiatric disease/disorder.
- History or presence of significance:
- Asthma, urticaria, or other allergic-type reactions after taking Torsemide, Spironolactone or any other drug. Ulceration or history of gastric and/or duodenal ulcer. Stomach or intestinal bleeding. Jaundice in the past 6 months. Internal bleeding.
- Hypersensitivity or allergy to Torsemide, Spironolactone or any of the excipients.
- History of alcohol or drug abuse in the past one year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 mg Torsemide tabletSingle dose 10 mg Torsemide tablet | Drug | Treatment A, Treatment D |
| 25 mg Aldactone (Spironolactone) tabletSingle dose 25 mg Aldactone® (Spironolactone) tablet | Drug | Treatment B, Treatment D |
| FDC (12 mg ER Torsemide + 15mg Spironolactone) tabletSingle dose FDC (12 mg ER Torsemide + 15 mg Spironolactone) tablet | Drug | Treatment C |
Primary outcome
Bioequivalence and bioavailability of the FDC to each of its components
Time frame: Through study completion: at least 27 days with minimum 7 days washout periods between testing
Compare bioequivalence and bioavailability (BE and BA) of the FDC to each of the components of the FDC, administered either individually or together: 10 mg Torsemide alone, 25 mg Spironolactone alone and 10 mg Torsemide and 25 mg Spironolactone taken together. Torsemide, Spironolactone, and Canrenone data will be used to estimate the following: Primary pharmacokinetic parameters: Cmax, AUC0-t and AUC0-inf.
Urinary torsemide excretion
Time frame: Through study completion: at least 27 days with minimum 7 days washout periods between testing
Urinary torsemide excretion: Rmax, Ae0-24, tmax and percentage drug recovered.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salim Shah, PhD, JD study chair
Sarfez Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10 mg Torsemide tablet, 25 mg Aldactone (Spironolactone) tablet and FDC (12 mg ER Torsemide + 15mg Spironolactone) tablet in people with Bioequivalence Study in Healthy Subjects and PK/PD, run by Sarfez Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence and bioavailability of the FDC to each of its components (time frame: Through study completion: at least 27 days with minimum 7 days washout periods between testing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.