Bioavailability and Bioequivalence Study of Extended Release Torsemide and Spironolactone

Bioavailability and Bioequivalence (BA/BE) Study of Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) Tablet in Healthy Adult Human Subjects

NCT07046975•Sarfez Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

To study intrasubject variability and steady-state pharmacokinetics of the multiple-doses of Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) (12 mg ER Torsemide and 15 mg Spironolactone) tablet and 10 mg Torsemide and 25 mg Aldactone® (Spironolactone) tablets given together in healthy adult subjects. In addition, torsemide, sodium, potassium, and creatinine will be measured in the urine samples.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects must fulfill all of the following criteria to be considered for inclusion into this study:
•1. Healthy human adult subjects within the age range of 18 to 45 years \[both inclusive\].
•2. Weight not less than 50 kg for male and 45 kg for female and BMI 18.50 to 29.99 kg/m2 \[both inclusive\].
•3. Willingness to provide written informed consent to participate in the study.
•4. 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.
•5. Free of significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG, Chest X-ray \[PA view\].
•6. Absence of disease markers of HIV 1 and 2, Hepatitis B and C and Syphilis.
•7. Subject should be literate.
•8. 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.
•9. 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).

Exclusion Criteria

•Any of the following conditions are cause for exclusion from the study:
•1. History or presence of significant: cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, musculoskeletal, psychiatric disease/disorder.
•2. 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.
•3. Hypersensitivity or allergy to Torsemide, Spironolactone or any of the excipients.
•4. History of alcohol or drug abuse in the past one year.
•5. Family history of bleeding disorders.
•6. History of difficulty in passing urine or emptying the bladder or of incontinence.
•7. Have donated 500 mL or more blood within 90 days before receiving the first dose of the study drug.
+16 more criteria

Locations (1)

Sarfez Pharmaceuticals

Vienna, Virginia, United States

Key Dates

Start Date

June 15, 2025

Primary Completion Date

February 28, 2026

Completion Date

February 28, 2026

Last Updated

March 9, 2026

Enrollment

ACTUAL participants

Conditions

Bioavailability Heathy Volunteers

Interventions

Torsemide and Spironolactone tablet

DRUG

Torsemide Tablets and Spironolactone Tablets

DRUG