Bioavailability and Bioequivalence Study of Extended Release Torsemide and Spironolactone

NCT07046975 | Completed Phase 3 FDA Drug

• 1 other identifier: SAR-HS-027-24
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To study intrasubject variability and steady-state pharmacokinetics of multiple-doses of Extended Release Torsemide and Spironolactone Fixed Dose Combination (FDC) tablets given together in healthy adult subjects.

Conditions

Bioavailability Heathy Volunteers

Keywords

Torsemide; Spironolactone; Combination; Bioavailability

Outcome Measures

Primary Outcomes (9)

• Plasma (Blood) sample analysis of torsemide for Cmax

  Measurement of torsemide in the blood for Cmax.

  24 hours

• Plasma (Blood) sample analysis of torsemide for AUC

  Measurement of torsemide in the blood for AUC.

  24 hours

• Plasma (Blood) sample analysis of Spironolactone and Canrenone for Cmax

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

  24 hours

• Plasma (Blood) sample analysis of AUC in the blood for Spironolactone and Canrenone

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

  24 hours

• Urine sample analysis to determine urinary excretion

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

  24 hours

• Urine sample analysis for torsemide secretion

  Calculate percentage of torsemide recovered in the urine.

  24 hours

• Urine sample analysis of torsemide for Rmax

  Urinary torsemide excretion will be measured for Rmax.

  24 hours

• Urine sample analysis for electrolytes

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

  24 hours

• Urine sample analysis for creatinine

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

  24 hours

Study Arms (2)

Arm 1 FDC

ACTIVE COMPARATOR

Fixed Dose Combination (FDC) 12 mg ER Torsemide and 15 mg Spironolactone tablet

Drug: Torsemide and Spironolactone tablet; Drug: Torsemide Tablets and Spironolactone Tablets

Arm 2 (Torsemide tablets and Spironolactone tablets)

ACTIVE COMPARATOR

10 mg Torsemide and 25 mg Spironolactone tablets given together

Drug: Torsemide and Spironolactone tablet; Drug: Torsemide Tablets and Spironolactone Tablets

Interventions

Torsemide and Spironolactone tablet DRUG

Fixed Dose Combination (FDC): (12 mg Extended Release (ER) Torsemide and 15 mg Spironolactone) tablet

Arm 1 FDC; Arm 2 (Torsemide tablets and Spironolactone tablets)

Torsemide Tablets and Spironolactone Tablets DRUG

10 mg Torsemide tablet and 25 mg Spironolactone tablet given together

Arm 1 FDC; Arm 2 (Torsemide tablets and Spironolactone tablets)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \[PA view\].
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sarfez Pharmaceuticals, Inc.: lead

Study Sites (1)

Sarfez Pharmaceuticals

Vienna, Virginia, 22182, United States

Location

MeSH Terms

Interventions

Torsemide; Spironolactone

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lactones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Salim Shah, PhD, JD

  Sarfez Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study is of randomized open label design; as it is not essential to design the study as double-blind for assessing bioavailability of formulations. The analyst will not have access to the randomization scheme.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, randomized, two-period, two-sequence, balanced, multiple-dose crossover intrasubject variability and steady-state BA/BE study

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: July 2, 2025
• Study Start: June 15, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)