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| Name | Class |
|---|---|
| ClinPharmInvest, LLC | OTHER |
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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 (Viagra®, 100 mg film-coated tablets) or the test (Sildenafil, 100 mg film-coated tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence TR | Other | 22 subjects assigned to the sequence TR will receive a single 100 mg dose of the test product Sildenafil (1 x 100 mg tablet), marked as T in the sequence, in Period 1 and a single 100 mg dose of the reference product Viagra® (1 x 100 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. |
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| Sequence RT | Other | 22 subjects assigned to the sequence RT will receive a single 100 mg dose of the reference product Viagra® (1 x 100 mg tablet), marked as R in the sequence, in Period 1 and a single 100 mg dose of the test product Sildenafil (1 x 100 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil film-coated tablet 100 mg | Drug | Sildenafil is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 100 mg of sildenafil. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax of sildenafil and N-Desmethyl Sildenafil 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, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration. |
| AUC0-t of sildenafil and N-Desmethyl Sildenafil 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, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of sildenafil and N-Desmethyl Sildenafil 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, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veronika Kumpel | Contact | 80173094418 | specialist.fs@ft.by | |
| Andrei Yaremchuk | Contact | development@ft.by |
| 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 | 150047 | Russia |
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| Viagra® film-coated tablet 100 mg | Drug | Viagra® is manufactured by Fareva Amboise, France. Each tablet contains 100 mg of sildenafil. |
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| TLQC of sildenafil and N-Desmethyl Sildenafil 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, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration. |
| AUC0-INF of sildenafil and N-Desmethyl Sildenafil 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, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration. |
| Residual area of sildenafil and N-Desmethyl Sildenafil 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, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 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 sildenafil and N-Desmethyl Sildenafil 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, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration. |
| λZ of sildenafil and N-Desmethyl Sildenafil 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, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration. |
| Terminal elimination half-life (Thalf) of sildenafil and N-Desmethyl Sildenafil 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, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 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, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration. |