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| Name | Class |
|---|---|
| National Anti Doping Laboratory, Belarus | UNKNOWN |
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The study is designed in accordance with the Eurasian Economic Union (EAEU) regulatory guidelines, with the aim of characterizing the bioavailability of two pharmaceutical products of sunitinib in healthy adult volunteers. Within the clinical portion of the study, each volunteer will receive a single oral dose of the test and the reference product in compliance with the generated randomization code.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence TR | Other |
| |
| Sequence RT | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aviga, capsules 50 mg / Sutent®, capsules 50 mg | Drug | Aviga is manufactured by JLLC NATIVITA, Republic of Belarus. Each capsule contains 50 mg of Sunitinib / Sutent® is manufactured by Pfizer Italia S.R.L., Italia. Each capsule contains 50 mg of Sunitinib. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of sunitinib for the test and the reference products | The maximum concentration in plasma among observed concentrations at pre-specified time points | Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing |
| AUC0-t of sunitinib for the test and the reference products | The area under the plasma concentration versus time curve from time 0 to the last measured concentration | Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ of sunitinib for the test and the reference products | The area under the plasma concentration versus time curve from time 0 to to infinite time | Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadia Malich | Contact | +375291093700 | nadzeya.malich@nativita.com | |
| Andrei Shnipov | Contact | andrei.shnipov@nativita.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Anti-Doping Laboratory | Lyasny | Minsk Oblast | 223040 | Belarus |
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|
| Sutent®, capsules 50 mg / Aviga, capsules 50 mg | Drug | Sutent® is manufactured by Pfizer Italia S.R.L., Italia. Each capsule contains 50 mg of Sunitinib / Aviga is manufactured by JLLC NATIVITA, Republic of Belarus. Each capsule contains 50 mg of Sunitinib |
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| Tmax of sunitinib for the test and the reference products |
The time to maximum measured plasma concentration |
| Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing |
| Kel of sunitinib for the test and the reference products | The elimination rate constant | Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing |
| T1/2 of sunitinib for the test and the reference products | Plasma Elimination Half-Life | Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing |
| AUCresid of sunitinib for the test and the reference products | Residual area under the pharmacokinetic curve from the time of the last measured concentration to infinite time | Time points: 0,00 (within 30 minutes before dosing) and 1; 2; 3; 4; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 10,5; 11; 11,5; 12; 13; 14; 16; 24; 36; 48; 72 hours after dosing |
| Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol | An AE is defined as any untoward medical occurrence in a subject administered the test or the reference product and which does not necessarily have a causal relationship with the treatment. | Up to 39 days |
| ID | Term |
|---|---|
| D002214 | Capsules |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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