A Study to Evaluate the Effect of Food or no Food on the Bioavailability of an Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) Tablet in Healthy Adult Subjects

NCT07043634 | Completed Phase 3 FDA Drug

• 1 other identifier: SAR-HS-004-24
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine comparative bioavailability of single dose of a fixed dose combination (FDC) of extended release Torsemide and Spironolactone given with or without food in healthy adult subjects.

Conditions

Bioavailability Heathy Volunteers

Keywords

extended release; diuretic; loop diuretic; Torsemide; Spironolactone

Outcome Measures

Primary Outcomes (2)

• Urine sample

  Urine samples collected at each interval will be measured for the volume

  11 days

• Blood Sample

  Sample analysis (Torsemide, Spironolactone, and Canrenone (Active metabolite of spironolactone))

  Total duration is at least 11 days from day of check-in for Period 1 to end of Period 2.

Study Arms (2)

FDC (24 mg ER torsemide and 30 mg Spironolactone) tablet without food

ACTIVE COMPARATOR

FDC (24 mg ER torsemide and 30 mg Spironolactone) tablet without food

Combination Product: FDC (24 mg ER torsemide and 30 mg Spironolactone) without food; Combination Product: FDC (24 mg ER torsemide and 30 mg Spironolactone) with food

FDC (24 mg ER torsemide and 30 mg Spironolactone) tablet with food

ACTIVE COMPARATOR

FDC (24 mg ER torsemide and 30 mg Spironolactone) tablet with food

Combination Product: FDC (24 mg ER torsemide and 30 mg Spironolactone) without food; Combination Product: FDC (24 mg ER torsemide and 30 mg Spironolactone) with food

Interventions

FDC (24 mg ER torsemide and 30 mg Spironolactone) without food COMBINATION_PRODUCT

FDC without food

FDC (24 mg ER torsemide and 30 mg Spironolactone) tablet with food; FDC (24 mg ER torsemide and 30 mg Spironolactone) tablet without food

FDC (24 mg ER torsemide and 30 mg Spironolactone) with food COMBINATION_PRODUCT

FDC with food

FDC (24 mg ER torsemide and 30 mg Spironolactone) tablet with food; FDC (24 mg ER torsemide and 30 mg Spironolactone) tablet without food

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 food for at least 10 h prior to start of consumption of high-fat high-calorie breakfast and at least 4 h post dose.
• Subject who refuses to consume the 100% high fat high calorie breakfast prior to dosing\*.
• 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).

Sponsors & Collaborators

• Sarfez Pharmaceuticals, Inc.: lead

Study Sites (1)

Sarfez Pharmaceuticals

Vienna, Virginia, 22182, United States

Location

MeSH Terms

Interventions

Spironolactone

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

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, two-period, two-sequence, balanced, single-dose crossover BA study of the FDC given with or without food.

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 29, 2025
• Study Start: June 15, 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)