Bioavailability and Bioequivalence Study of ER Torsemide and Spironolactone FDC Tablet in Healthy Subjects

NCT07015671 | Completed Phase 3 FDA Drug

• 1 other identifier: SAR-HS-025-23
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 Torsemide and 25 mg Aldactone® (Spironolactone) taken together in healthy subjects.

Conditions

PK/PD; Bioequivalence Study in Healthy Subjects

Keywords

torsemide; Spironolactone; bioequivalence; diuresis; extended release; immediate release; PK/PD

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Through study completion: at least 27 days with minimum 7 days washout periods between testing

Study Arms (4)

Treatment A

EXPERIMENTAL

10 mg Torsemide tablet

Drug: 10 mg Torsemide tablet

Treatment B

EXPERIMENTAL

25 mg Aldactone (Spironolactone) tablet

Drug: 25 mg Aldactone (Spironolactone) tablet

Treatment C

EXPERIMENTAL

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

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

Treatment D

EXPERIMENTAL

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

Drug: 10 mg Torsemide tablet; Drug: 25 mg Aldactone (Spironolactone) tablet

Interventions

10 mg Torsemide tablet DRUG

Single dose 10 mg Torsemide tablet

Treatment A; Treatment D

25 mg Aldactone (Spironolactone) tablet DRUG

Single dose 25 mg Aldactone® (Spironolactone) tablet

Treatment B; Treatment D

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

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

Treatment C

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.
• Found positive screening results for Hepatitis B, Hepatitis C, HIV, or Syphilis.

Sponsors & Collaborators

• Sarfez Pharmaceuticals, Inc.: lead

Study Sites (1)

Sarfez Pharmaceuticals

Vienna, Virginia, 22182, United States

Location

MeSH Terms

Interventions

Torsemide; Spironolactone; Tablets

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; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Salim Shah, PhD, JD

  Sarfez Pharmaceuticals, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: July 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)