Actively Recruiting
Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
NCT07201584
A Comparative Bioavailability Study of Two Torasemide 10 mg Tablets Formulations in Healthy Adult Participants Under Fasting Conditions:
Led by Berlin-Chemie AG Menarini Group · Updated on 2026-01-14
26
Participants Needed
1
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Comparative Bioavailability Study of Two Torasemide 10 mg Tablets Formulations in Healthy Adult Participants Under Fasting Conditions:
Who Can Participate
Age: 18Years - 55Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Known hypersensitivity or intolerance to torasemide, other sulfonylureas, or any excipient of the investigational medicinal products.
- History of renal failure with anuria.
- History of hepatic precoma or coma.
- History of hypotension.
- History of hypovolemia.
- History of hyponatremia and/or hypokalemia.
- History of substantial micturition disorders such as due to prostatic hypertrophy.
- History of gout.
- History of cardiac arrhythmias including sinoatrial block or 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 blood count such as thrombocytopenia or anemia (without renal insufficiency).
- History of abnormally high LDL cholesterol levels (≥190 mg/dL) within 3 months before first dose.
- Abnormally high triglycerides levels (>150 mg/dL) within 3 months before first dose.
- History of renal insufficiency with creatinine clearance between 20 and 30 mL/min or serum creatinine between 3.5 and 6 mg/dL due to nephrotoxic substances.
- History of other clinically significant cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal, hematological, genito-urinary, bleeding, neurological, psychiatric, oncologic, autoimmune, dermatological, or other chronic diseases making the participant ineligible.
- Acute infectious diseases within 4 weeks before first dose including influenza, respiratory infections, or COVID-19.
- Hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
- Systolic blood pressure <90 mmHg or ≥130 mmHg, or diastolic blood pressure <60 mmHg or ≥85 mmHg.
- Heart rate <60 or >100 beats per minute.
- Any condition that may put the participant at risk or affect study participation or results, as judged by the Investigator.
- Use of medications affecting circulatory dynamics or liver function (e.g., barbiturates, omeprazole, cimetidine, NSAIDs, ACE inhibitors, angiotensin II receptor antagonists, diuretics) within 2 months before first dose.
- Use of depot medication forms within 3 months before first dose.
- Use of any other prescribed or non-prescribed medications, herbal remedies, vitamins, or minerals within 2 weeks before first dose or longer if long half-life.
- Female individuals who are lactating.
- Female individuals of childbearing potential having unprotected sex with unsterilized male partner within 30 days before first dose.
- Blood donation or loss >450 mL within 60 days or apheresis donation within 30 days before first dose.
- Dehydration within 48 hours before first dose.
- Positive COVID-19 rapid antigen test at study admission.
- Positive tests for HIV, hepatitis B or C, or syphilis at screening.
- History of drug or alcohol abuse within 1 year before screening; alcohol abuse defined as >10 units per week.
- Positive screen for drugs or alcohol at screening.
- Special diet within 28 days before first dose and throughout study.
- Intake of methylxanthine-containing substances and certain fruits within 48 hours before first dose.
- Intake of poppy seed-containing food or beverages within 72 hours before first dose.
- Excessive caffeine consumption (>6 servings per day) within 2 weeks before first dose.
- Mental or physical conditions preventing proper study participation.
- Participation in another clinical study (except no investigational product) within 3 months before first dose.
- Employee or family member of Sponsor, CRO, or Study Site.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
LLP MedStartUp
Almaty, Ili District, Otegen Batyr Settlement, Kazakhstan
Actively Recruiting
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Research Team
K
Kai Schumacher, MD
CONTACT
A
Anja Pagenkopf
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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