Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ClinPharmInvest, LLC | OTHER |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Torasemide tablet 10 mg | Drug | Torasemide is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 10 mg of torasemide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of torasemide in plasma after administration of the test and the reference products | Maximum observed concentration in plasma. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
Not provided
Inclusion Criteria:
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:
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
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexander Khokhlov | ClinPharmInvest, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private healthcare institution "Clinical Hospital "RZD-Medicine" of the city of Yaroslavl" | Yaroslavl | Yaroslavl Oblast | 150047 | Russia |
Not provided
| ID | Term |
|---|---|
| D000077786 | Torsemide |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Toradiur® tablet 10 mg | Drug | Toradiur® is manufactured by MEDA Manufacturing Cologne, Germany. Each tablet contains 10 mg of torasemide. |
|
|
| TLQC of torasemide in plasma after administration of the test and the reference products. | Time of last observed quantifiable concentration. | 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). | 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). | 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 | 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. | 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. | 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. | 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 |
| Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |