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New treatment option for Healthy Adult Male and Female Volunteers
Official title A Comparative Bioavailability Study of Two Torasemide 10 mg Tablets Formulations in Healthy Adult Participants Under Fasting Conditions:
ClinicalTrials.gov ID: NCT07201584
What this study is testing
What is Torasemide tablet 10 mg?
Torasemide tablet 10 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy adult male and female volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join 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...
- 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...
You likely can't join 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.
See the full eligibility criteria
- 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]...
- 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...
- 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%...
- 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.
- 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.
- History of other clinically significant cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal, hematological, genito-urinary disease, bleeding disorders, neurological or psychiatric...
- Acute infectious diseases (e.g. influenza, acute respiratory bacterial or viral infections incl. COVID-19) less than 4 weeks before the first IMP dose.
- Hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
- Systolic blood pressure \< 90 mmHg or ≥ 130 mmHg and/or diastolic blood pressure \< 60 mmHg or ≥ 85 mmHg.
- Heart rate \ 100 beats per minute.
- The presence of any other condition which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to...
- Use of the following medications within the relevant period before the first IMP dose:
- Use of medications (including hormonal contraceptives) that have a significant effect on circulatory dynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, non-steroidal anti-inflammatory drugs...
- Use of depot-forms of any medications within 3 months before the first IMP dose.
- Use of any other prescribed or non-prescribed medication, herbal remedies, vitamins and minerals within 2 weeks before the first IMP dose or longer (at least 5 elimination half-lives) if the medication has a long...
- Female individuals who are lactating.
- Female individuals of childbearing potential, having unprotected sexual intercourse with any unsterilized male partner (i.e., a man who is not sterilized by vasectomy for at least 6 months) within 30 days before the...
- Blood donation/blood loss \>450 mL within 60 days or apheresis donation within 30 days before the first IMP dose.
- Dehydration (e.g. due to diarrhea, vomiting, or other causes) within the last 48 h before the first IMP dose.
- Positive test result for COVID-19 rapid antigen test at admission to the Study Site.
- Positive test results for HIV or hepatitis B (HBsAg, anti-HBc) or C (anti-HCV) or syphilis at screening.
- History of drug or alcohol abuse within 1 year before the screening. Alcohol abuse is defined as regular intake of more than 10 units of alcohol a week (1 unit equivalent to 200 mL of dry wine or 50 mL of strong...
- Positive screen for drugs or alcohol at screening.
- Individuals who have been on a special diet (for whatever reason, e.g. vegetarians or hypocaloric diet [\< 1000 kcal/day]) within the 28 days before the first IMP dose and throughout the study.
- Intake of methylxanthine-containing substances (e.g., coffee, tea, chocolate, cocoa, energy drinks, cola) as well as citrus fruits and cranberry (including juices, fruit drinks, etc.) within the last 48 h before the...
- Intake of food or beverages containing poppy seeds within 72 h before the first IMP dose.
- Excessive consumption (defined as greater than 6 servings - 1 serving being approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks or other caffeinated beverages per day within 2 weeks...
- Mental, physical and other reasons that do not allow the individual, according to Investigator's opinion, to assess their behavior adequately, to follow correctly the requirements of the clinical study protocol and to...
- Participation in another clinical study (except if no investigational product was administered) within 3 months before the first IMP dose.
- Employee or family member of the Sponsor or the involved Contract Research Organization (CRO) or the Study Site.
The study team makes the final eligibility decision.
Where it's taking place
- Almaty, Ili District, Otegen Batyr Settlement, Kazakhstan
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Almaty, Ili District, Otegen Batyr Settlement, Kazakhstan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.