BioequivalencePhase 1NCT04921566
Bioequivalence Study of Two Formulations of Torasemide Tablet 10 mg in Healthy Volunteers Under Fasting Conditions
A Phase 1 study testing Torasemide tablet 10 mg and Toradiur® tablet 10 mg in people with Bioequivalence, run by Pharmtechnology LLC at 1 site in Russia.
Trial summary
This is an open-labeled (laboratory blinded), randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Toradiur®, 10 mg) or the test (Torasemide, 10 mg) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Torasemide tablet 10 mg and Toradiur® tablet 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 siteRussia
- Study dates
- 5 Jun 2021to 20 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy caucasian men and women aged between 18 to 45 years
- Verified diagnosis "healthy" according to the anamnesis data and the results of standard clinical, laboratory and instrumental examination methods, physical examination and anamnestic examination
- Body mass index 18.5-30 kg/m² according to Quetelet's weight-height index
- The results of an X-ray or fluorographic examination of the chest organs within the normal range (the results of an examination carried out within 12 months before the start of the study may be provided)
- For female subject:
- the results of the examination of the mammary glands (palpation or mammography) within the normal range according to the data obtained within 12 months before the start of the study;
Show all 12Show fewer
- non-breastfeeding women, negative pregnancy test and the consent to adhere to adequate methods of contraception from the moment of signing the informed consent form and up to 30 days after taking the drug in the second period of the study;
- reliable methods of contraception: sexual continence, or condom + spermicide, or diaphragm + spermicide, started at least 14 days before the first dose of the study drug; intrauterine contraception is also a reliable method of contraception, installed at least 4 weeks before taking the study drugs in the first period;
- in case of using hormonal contraceptives, the latter should be canceled at least 2 months before taking the drug in the first period;
- women who do not use acceptable methods of contraception, if they are considered incapable of childbearing, will also be able to participate in the study: women who have undergone a hysterectomy or tubal ligation, women with a clinical diagnosis of infertility, and women who are in menopause (at least a year without menstruation in the absence of alternative pathologies that may cause the cessation of menstruation).
- For male: consent to use a double barrier method of contraception (condom + spermicide) or complete sexual abstinence, as well as consent not to participate in sperm donation during the entire study and 90 days after taking the drug in the second period
- Subjects are able to understand the requirements of the study, to sign a written informed consent, and also to accept all the restrictions imposed during the course of the study, and to agree to return for the required investigations
Who cannot join
- burdened allergic history, hypersensitivity to torasemide or excipients that are part of any of the investigational drugs, or intolerance to these components;
- clinically significant pathologies of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys and blood;
- other diseases that, in the opinion of the researcher, may affect the absorption, distribution, metabolism or excretion of both drugs, or increase the risk of negative consequences for the volunteer;
- the presence of mental disorders, including a history;
- surgical interventions on the gastrointestinal tract, with the exception of appendectomy;
- acute infectious diseases that ended less than 4 weeks before taking the drug in the first period;
Show all 32Show fewer
- dehydration due to diarrhea, vomiting or other reason within the last 24 hours before taking the drug in the first period of the study;
- clinically significant abnormalities on the ECG, the level of systolic blood pressure (SBP) measured in the sitting position at the time of screening ≤ 100 mm Hg or ≥ 130 mm Hg and / or diastolic blood pressure (DBP) ≤ 60 mm Hg or ≥ 85 mm Hg;
- heart rate less than 60 beats/min or more than 90 beats/min at the time of screening, respiratory rate less than 12 or more than 18 per minute at the time of screening, body temperature below 36.0 ° C or above 37.0 °C at the time of screening;
- the use of injectable and oral hormonal contraceptives, subcutaneous hormonal implants or intrauterine hormonal therapeutic systems and other hormonal contraceptives for 60 days before taking the drug in the first period;
- use of well-known inhibitors or inducers of liver microsomal enzymes less than 30 days before enrollment in the study;
- use of any drugs including herbs and food additives, vitamins that can have a significant effect on the PK of torasemide or data on the effect of which on the pharmacokinetics of torasemide are unknown, as well as question the characterization of the volunteer as healthy, less than 14 days before taking the drug in the first period;
- donation of plasma or blood (450 ml or more) less than 2 months (60 days) before taking the drug in the first period;
- consumption of caffeine and xanthine-containing drinks and products (tea, coffee, chocolate, cola, etc.), products containing poppy seeds, less than 48 hours before taking the drug in the first period;
- consumption of alcohol and alcohol-containing foods and beverages less than 48 hours before taking the drug in the first period;
- use of citrus fruits (including grapefruit and grapefruit juice) and cranberries (including juices, fruit drinks, etc.) less than 7 days before taking the drug in the first period;
- intake of more than 10 units alcohol per week (1 unit of alcohol is equivalent to 500 ml of beer, 200 ml of dry wine or 50 ml of spirits ethyl 40%) or history of alcoholism, drug addiction, drug abuse;
- smoking more than 10 cigarettes per day less than 48 hours before taking the drug in the first period;
- inability to refrain from intensive physical activity and contact sports less than 24 hours before taking the drug in the first period;
- participation in other clinical trials of drugs less than 3 months before taking the drug in the first period;
- test positive for syphilis, hepatitis B, hepatitis C or HIV at the time of screening;
- positive pregnancy test at screening;
- breastfeeding;
- positive test for alcohol in exhaled air at screening;
- positive urinalysis for the content of narcotic and potent substances during screening (opiates, morphine, barbiturates, benzodiazepines, cannabinoids/marijuana);
- the value of standard laboratory and instrumental parameters that go beyond the reference values;
- lack of intention of volunteers to comply with the Protocol requirements throughout the course of the study and/or lack, in the opinion of the Investigator, of the volunteers' ability to understand and evaluate the information on this study as part of the informed consent form signing process, in particular regarding the expected risks and possible discomfort;
- tattooing and piercing within 30 days prior to first drug administration;
- difficulty swallowing tablets;
- a history of lactase deficiency, galactose intolerance, glucose/galactose malabsorption (the tablets of the tested and reference drugs contain lactose);
- difficulty with taking blood (for example, difficult access to the veins);
- using special diets (eg fasting, etc.) or diets (eg, protein, vegetarian, vegan, etc.).
Trial locations and contacts
1 site in 1 country.
Russia1 site
Private healthcare institution "Clinical Hospital "RZD-Medicine" of the city of Yaroslavl"
Yaroslavl, Yaroslavl Oblast, 150047
About this study
Official title: Randomized Crossover 2 Period Single Dose Bioequivalence Study of 2 Formulations Torasemide Tab. 10mg (Pharmtechnology LLC,Belarus) and Toradiur® Tab. 10mg (MEDA Manufacturing Cologne, Germany) in Healthy Volunteers Under Fasting Conditions
This is an open-labeled (laboratory blinded), randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Toradiur®, 10 mg) or the test (Torasemide, 10 mg) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent
- Conditions
- Bioequivalence
- Being tested
- Torasemide tablet 10 mg, Toradiur® tablet 10 mg
- Keywords
- Torasemide, Bioequivalence, Toradiur®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Torasemide tablet 10 mgDrug
Also called The test product
Torasemide is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 10 mg of torasemide.
Toradiur® tablet 10 mgDrug
Also called The reference product
Toradiur® is manufactured by MEDA Manufacturing Cologne, Germany. Each tablet contains 10 mg of torasemide.
| Study group | Role | What they receive |
|---|---|---|
| Sequence TR | Other | 13 subjects assigned to the sequence TR will receive a single 10 mg dose of the test product Torasemide (1 x 10 mg tablet), marked as T in the sequence, in Period 1 and a single 10 mg dose of the reference product Toradiur® (1 x 10 mg tablet), marked as R in the sequence, in period 2. These treatments will be administered orally with approximately 200 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. Receives: Drug: Torasemide tablet 10 mg; Drug: Toradiur® tablet 10 mg |
| Sequence RT | Other | 13 subjects assigned to the sequence RT will receive a single 10 mg dose of the reference product Toradiur® (1 x 10 mg tablet), marked as R in the sequence, in Period 1 and a single 10 mg dose of the test product Torasemide (1 x 10 mg tablet), marked as T in the sequence, in period 2. These treatments will be administered orally with approximately 200 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. Receives: Drug: Torasemide tablet 10 mg; Drug: Toradiur® tablet 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of torasemide in plasma after administration of the test and the reference products
Maximum observed concentration in plasma.
Measured: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration.
AUC0-t of torasemide in plasma after administration of the test and the reference.
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method.
Measured: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
Secondary outcomes (8)
Tmax of torasemide in plasma after administration of the test and the reference products.
Time of maximum observed concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value.
Measured: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
TLQC of torasemide in plasma after administration of the test and the reference products.
Time of last observed quantifiable concentration.
Measured: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
AUC0-INF of torasemide in plasma after administration of the test and the reference products.
Area under the concentration time curve extrapolated to infinity, calculated as AUC0-t + ĈLQC (the predicted concentration at time TLQC) / λZ (apparent elimination rate constant).
Measured: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
Residual area of torasemide in plasma after administration of the test and the reference products.
Extrapolated area (i.e. percentage of AUC0-INF due to extrapolation from TLQC to infinity).
Measured: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
Time point where the log-linear elimination phase begins (TLIN) of torasemide in plasma after administration of the test and the reference. products.
Time point where the log-linear elimination phase begins
Measured: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
λZ of torasemide in plasma after administration of the test and the reference products
Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve.
Measured: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
Terminal elimination half-life (Thalf) of toresemide in plasma after administration of the test and the reference products.
Terminal elimination half-life, calculated as ln(2)/λZ.
Measured: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
Number of treatment-emergent adverse events for the test and the reference products.
The safety population will include all subjects who received at least one dose of the test or the reference product. Any significant changes will be recorded as treatment-emergent adverse events only if they are judged clinically significant by the qualified investigator or delegate.
Measured: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start5 Jun 2021
- Primary completion20 Jun 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmtechnology LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinPharmInvest, LLC
- Responsible party
- Sponsor
- Investigators
- Alexander Khokhlov, Principal investigator, ClinPharmInvest, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921566
- Sponsor's protocol ID
- TRSMD-2020
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Crossover 2 Period Single Dose Bioequivalence Study of 2 Formulations Torasemide Tab. 10mg (Pharmtechnology LLC,Belarus) and Toradiur® Tab. 10mg (MEDA Manufacturing Cologne, Germany) in Healthy Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT04921566
- Acronym / sponsor ID
- TRSMD-2020
- Conditions
- Bioequivalence
- Keywords
- Torasemide, Bioequivalence, Toradiur®
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Pharmtechnology LLCIndustry (pharma, biotech, devices)
- Collaborators
- ClinPharmInvest, LLC
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 10 Jun 2021 (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.
This is an open-labeled (laboratory blinded), randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Toradiur®, 10 mg) or the test (Torasemide, 10 mg) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence TR | Other | Drug: Torasemide tablet 10 mg, Drug: Toradiur® tablet 10 mg13 subjects assigned to the sequence TR will receive a single 10 mg dose of the test product Torasemide (1 x 10 mg tablet), marked as T in the sequence, in Period 1 and a single 10 mg dose of the reference product Toradiur® (1 x 10 mg tablet), marked as R in the sequence, in period 2. These treatments will be administered orally with approximately 200 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
| Sequence RT | Other | Drug: Torasemide tablet 10 mg, Drug: Toradiur® tablet 10 mg13 subjects assigned to the sequence RT will receive a single 10 mg dose of the reference product Toradiur® (1 x 10 mg tablet), marked as R in the sequence, in Period 1 and a single 10 mg dose of the test product Torasemide (1 x 10 mg tablet), marked as T in the sequence, in period 2. These treatments will be administered orally with approximately 200 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy caucasian men and women aged between 18 to 45 years
- Verified diagnosis "healthy" according to the anamnesis data and the results of standard clinical, laboratory and instrumental examination methods, physical examination and anamnestic examination
- Body mass index 18.5-30 kg/m² according to Quetelet's weight-height index
- The results of an X-ray or fluorographic examination of the chest organs within the normal range (the results of an examination carried out within 12 months before the start of the study may be provided)
- For female subject:
Key exclusion criteria (32 listed)
- burdened allergic history, hypersensitivity to torasemide or excipients that are part of any of the investigational drugs, or intolerance to these components;
- clinically significant pathologies of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys and blood;
- other diseases that, in the opinion of the researcher, may affect the absorption, distribution, metabolism or excretion of both drugs, or increase the risk of negative consequences for the volunteer;
- the presence of mental disorders, including a history;
- surgical interventions on the gastrointestinal tract, with the exception of appendectomy;
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 mgAlso: The test productTorasemide is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 10 mg of torasemide. | Drug | Sequence RT, Sequence TR |
| Toradiur® tablet 10 mgAlso: The reference productToradiur® is manufactured by MEDA Manufacturing Cologne, Germany. Each tablet contains 10 mg of torasemide. | Drug | Sequence RT, Sequence TR |
Primary outcome
Cmax of torasemide in plasma after administration of the test and the reference products
Time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration.
Maximum observed concentration in plasma.
AUC0-t of torasemide in plasma after administration of the test and the reference.
Time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method.
8 secondary outcomes
Tmax of torasemide in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
TLQC of torasemide in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
AUC0-INF of torasemide in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
Residual area of torasemide in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
Time point where the log-linear elimination phase begins (TLIN) of torasemide in plasma after administration of the test and the reference. products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
λZ of torasemide in plasma after administration of the test and the reference products
Time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
Terminal elimination half-life (Thalf) of toresemide in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
Number of treatment-emergent adverse events for the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
Related trials for Bioequivalence
Not yet recruitingPhase 1
A Study of Imlunestrant (LY3484356) in Healthy Female Participants
Healthy
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingPhase 1
Bioequivalence Study Between YHP2508B and YHR2602 in Healthy Subjects
Healthy Subjects (HS)
Active, not recruitingPhase 1
A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
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. This study is not recruiting at the moment.
Alexander Khokhlov principal investigator
ClinPharmInvest, LLC
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 Toradiur® tablet 10 mg in people with Bioequivalence, run by Pharmtechnology LLC at 1 site in Russia.
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 12 inclusion and 32 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: finished, as of the sponsor's last update on 29 Jun 2023. 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 Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of torasemide in plasma after administration of the test and the reference products (time frame: Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration.). 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 29 Jun 2023.