Healthy Adult Male and Female VolunteersPhase 1NCT07201584
A Comparative Bioavailability Study of Two Torasemide 10 mg Tablets Formulations in Healthy Adult Participants Under Fasting Conditions:
A Phase 1 study testing Torasemide tablet 10 mg and Unat® 10 tablets (Torasemide 10 mg) in people with Healthy Adult Male and Female Volunteers, run by Berlin-Chemie AG Menarini Group at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male and Female Volunteers
- What is being tested?
- Torasemide tablet 10 mg and Unat® 10 tablets (Torasemide 10 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteKazakhstan
- Study dates
- 5 Sep 2025to 1 Apr 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 40Show fewer
- 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 pathology, oncologic disease, autoimmune disease, dermatological disease or other chronic disease, that makes the individual ineligible for the study.
- 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 < 60 or > 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 participate in the study.
- 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, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, diuretics, etc.) within 2 months before the first IMP dose.
- 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 half-life.
- 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 first IMP dose.
- 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 alcoholic drinks or 500 mL of beer).
- 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 first IMP dose.
- 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 before the first IMP dose.
- 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 assess the expected risks and possible discomfort.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kazakhstan1 site, 1 recruiting
- Recruiting
LLP MedStartUp
Almaty, Ili District, Otegen Batyr Settlement
Guldana Abdullaeva, MD, +7 705 1708 ext. 825, PI_1@medstartup.asia
Marat Esimzhanov, MD, +7 705 710 88 ext. 25, PI_2@medstartup.asia
About this study
Official title: A Comparative Bioavailability of Two Torasemide 10 mg Tablets Formulations in Healthy Adult Participants Under Fasting Conditions: a Prospective, Open-label, Randomized, Single-dose, Two-treatment, Two-period, Two-sequence, Crossover Bioequivalence Study
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.
Read the detailed description
In this Phase I study, the test medication Torasemide 10 mg tablets (Berlin-Chemie AG) is compared to Unat® 10 tablets (Viatris Healthcare GmbH) in terms of bioequivalence of the tested formulations under fasting conditions
- Conditions
- Healthy Adult Male and Female Volunteers
- Being tested
- Torasemide tablet 10 mg, Unat® 10 tablets (Torasemide 10 mg)
- Keywords
- Torasemide, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Torasemide tablet 10 mgDrug
Tablets by Berlin-Chemie AG (Germany)
Unat® 10 tablets (Torasemide 10 mg)Drug
Tablets by Viatris Healthcare GmbH (Germany)
| Study group | Role | What they receive |
|---|---|---|
| Torasemide 10 mg tablet | Experimental | Single dose administration (10 mg) with 240 mL of water under fasting conditions Receives: 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 Receives: Drug: Unat® 10 tablets (Torasemide 10 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
C max
Maximum plasma concentration
Measured: 24 hours
AUC 0-last
Area under the curve from time 0 to the last quantifiable time point
Measured: 24 hours
Secondary outcomes (8)
AUC 0-Inf
Area under the curve from time 0 to infinity
Measured: Through study completion, an average of 1 year
T max
Time to maximum plasma concentration
Measured: 24 hours
C last
Last observed quantifiable concentration
Measured: 24 hours
T last
Time to last quantifiable concentration
Measured: 24 hours
T lag
Lag time
Measured: 24 hours
λz
Terminal elimination rate constant
Measured: 24 hours
T 1/2
Elimination half-life
Measured: 24 hours
Residual area
Residual area under the plasma concentration curve
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start5 Sep 2025
- Primary completion30 Dec 2025
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Male and Female VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, randomized, open-lable, , single-dose, two-period, two-treatment, two-sequence, crossover bioequivalence study
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Berlin-Chemie AG Menarini Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guldana Abdullaeva, MD, Principal investigator, LLP MedStartUp, Ili district, Otegen Batyr settlement, Industrial Zone 200A, Almaty region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201584
- Sponsor's protocol ID
- BCKZ/24/Tor-BE/001
- Status last verified
- Jan 2026
- First submitted
- 10 Sep 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No publication in an ICMJE journal is planned
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Bioavailability of Two Torasemide 10 mg Tablets Formulations in Healthy Adult Participants Under Fasting Conditions: a Prospective, Open-label, Randomized, Single-dose, Two-treatment, Two-period, Two-sequence, Crossover Bioequivalence Study
- ClinicalTrials.gov ID
- NCT07201584
- Acronym / sponsor ID
- BCKZ/24/Tor-BE/001
- Conditions
- Healthy Adult Male and Female Volunteers
- Keywords
- Torasemide, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Berlin-Chemie AG Menarini GroupIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this Phase I study, the test medication Torasemide 10 mg tablets (Berlin-Chemie AG) is compared to Unat® 10 tablets (Viatris Healthcare GmbH) in terms of bioequivalence of the tested formulations under fasting conditions
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, open-lable, , single-dose, two-period, two-treatment, two-sequence, crossover bioequivalence study
| Arm | Type | Receives |
|---|---|---|
| Torasemide 10 mg tablet | Experimental | Drug: Torasemide tablet 10 mgSingle dose administration (10 mg) with 240 mL of water under fasting conditions |
| Unat® 10 (Torasemide) tablets (Viatris Healthcare GmbH) | Experimental | Drug: Unat® 10 tablets (Torasemide 10 mg)Single dose administration (10 mg) with 240 mL of water under fasting conditions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (40 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Torasemide tablet 10 mgTablets by Berlin-Chemie AG (Germany) | Drug | Torasemide 10 mg tablet |
| Unat® 10 tablets (Torasemide 10 mg)Tablets by Viatris Healthcare GmbH (Germany) | Drug | Unat® 10 (Torasemide) tablets (Viatris Healthcare GmbH) |
Primary outcome
C max
Time frame: 24 hours
Maximum plasma concentration
AUC 0-last
Time frame: 24 hours
Area under the curve from time 0 to the last quantifiable time point
8 secondary outcomes
AUC 0-Inf
Time frame: Through study completion, an average of 1 year
T max
Time frame: 24 hours
C last
Time frame: 24 hours
T last
Time frame: 24 hours
T lag
Time frame: 24 hours
λz
Time frame: 24 hours
T 1/2
Time frame: 24 hours
Residual area
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. No publication in an ICMJE journal is planned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guldana Abdullaeva, MD principal investigator
LLP MedStartUp, Ili district, Otegen Batyr settlement, Industrial Zone 200A, Almaty region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Torasemide tablet 10 mg and Unat® 10 tablets (Torasemide 10 mg) in people with Healthy Adult Male and Female Volunteers, run by Berlin-Chemie AG Menarini Group at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Schumacher, MD (+49 (0)30 6707 ext. 2357, kaischumacher@berlin-chemie.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C max (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.