A Comparative Bioavailability Study of Two Torasemide 10 mg Tablets Formulations in Healthy Adult Participants Under Fasting Conditions:

NCT07201584 | Recruiting Phase 1

• 1 other identifier: BCKZ/24/Tor-BE/001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the bioavailability, safety and tolerability of Torasemide 10 mg tablets (Berlin-Chemie AG), compared to Unat® 10 tablets (Viatris Healthcare GmbH) in healthy adult participants under fasting conditions.

Conditions

Healthy Adult Male and Female Volunteers

Keywords

Torasemide; Bioequivalence

Outcome Measures

Primary Outcomes (2)

• C max

  Maximum plasma concentration

  24 hours

• AUC 0-last

  Area under the curve from time 0 to the last quantifiable time point

  24 hours

Secondary Outcomes (8)

• AUC 0-Inf

  Through study completion, an average of 1 year

• T max

  24 hours

• C last

  24 hours

• T last

  24 hours

• T lag

  24 hours

Other Outcomes (6)

• Analysis of Adverse Events (AEs)

  28 days

• Analysis of Adverse Events (AEs)

  28 days

• Analysis of Adverse Events (AEs)

  28 days

Study Arms (2)

Torasemide 10 mg tablet

EXPERIMENTAL

Single dose administration (10 mg) with 240 mL of water under fasting conditions

Drug: Torasemide tablet 10 mg

Unat® 10 (Torasemide) tablets (Viatris Healthcare GmbH)

EXPERIMENTAL

Single dose administration (10 mg) with 240 mL of water under fasting conditions

Drug: Unat® 10 tablets (Torasemide 10 mg)

Interventions

Torasemide tablet 10 mg DRUG

Tablets by Berlin-Chemie AG (Germany)

Torasemide 10 mg tablet

Unat® 10 tablets (Torasemide 10 mg) DRUG

Tablets by Viatris Healthcare GmbH (Germany)

Unat® 10 (Torasemide) tablets (Viatris Healthcare GmbH)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female individuals aged 18 to 55 years inclusive at the time of signing the ICF.
• Body weight ≥50 kg and Body Mass Index (BMI) between ≥18.5 and \<30.0 kg/m2.
• A healthy individual as determined by the Investigator based on medical history and results of standard clinical, laboratory and instrumental methods of examination (individuals with not clinically significant \[NCS\] abnormalities are eligible for the study).
• A non-smoker (for at least 3 months before screening), verified by the cotinine test at screening.
• A negative urine pregnancy test (rapid test) within 24 h before the first IMP dose for female individuals of childbearing potential. Postmenopausal (no menses for at least 1 year) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) females are exempted from the requirement.
• Individuals with preserved reproductive potential should agree to use, with their partner, adequate contraception throughout the study and for 30 days thereafter (contraceptive methods with reliability greater than 90%: cervical caps with spermicide, diaphragms with spermicide, condoms with intravaginal spermicide, non-hormonal intrauterine devices), or true sexual abstinence.
• Capable of understanding the ICF and giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and the study protocol.

You may not qualify if:

• Known hypersensitivity or intolerance to torasemide, other sulfonylureas, or any other excipient of the IMPs.
• History of renal failure with anuria.
• History of hepatic precoma, coma.
• History of hypotension.
• History of hypovolemia.
• History of hyponatremia and/or hypokalemia.
• History of substantial micturition disorders (e.g. due to prostatic hypertrophy).
• History of gout.
• History of cardiac arrhythmias (e.g. SA block, 2nd or 3rd degree AV block).
• History of latent or manifest diabetes mellitus or any form of hyperglycemia.
• History of pathological changes in the acid-base balance.
• History of pathological changes in the blood count (e.g. thrombocytopenia, anemia in patients without renal insufficiency).
• History of abnormally high (≥190 mg/dL \[≥4.9 mmol/L\]) low-density lipoprotein (LDL) cholesterol levels within 3 months before the first IMP dose.
• Abnormally high triglycerides levels (\>150 mg/dL \[\>1.7 mmol/L\]) within 3 months before the first IMP dose.
• History of renal insufficiency (creatinine clearance between 20 mL and 30 mL/min and/or serum creatinine concentrations between 3.5 mg/dL and 6 mg/dL) due to nephrotoxic substances.

Sponsors & Collaborators

• Berlin-Chemie AG Menarini Group: lead

Study Sites (1)

LLP MedStartUp

Almaty, Ili District, Otegen Batyr Settlement, Kazakhstan

RECRUITING

Related Links

• Related Info

MeSH Terms

Interventions

Torsemide

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Guldana Abdullaeva, MD

  LLP MedStartUp, Ili district, Otegen Batyr settlement, Industrial Zone 200A, Almaty region

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Schumacher, MD

CONTACT

+49 (0)30 6707; kaischumacher@berlin-chemie.de

Anja Pagenkopf

CONTACT

+49 6707; apagenkopf@berlin-chemie.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, open-lable, , single-dose, two-period, two-treatment, two-sequence, crossover bioequivalence study

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: October 1, 2025
• Study Start: September 5, 2025
• Primary Completion: December 30, 2025
• Study Completion: April 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)