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| ID | Type | Description | Link |
|---|---|---|---|
| DASAT-BIO-001-2022 | Other Identifier | CAIMED |
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A bioequivalence study of Dasatinib will be carried out in 46 healthy subjects, in fed condition, following the complete replicated design, randomized, comparative of 2 sequences, 2 study formulations, in a single dose of 100 mg of Dasatinib tablets / coated tablets, 4 periods. , with a washout time of 7 days between each dose
A bioequivalence study of Dasatinib in 46 healthy subjects, in fed condition, complete replicated design, comparative of 2 sequences, 2 formulations, single dose of 100 mg of Dasatinib tablets / coated tablets, 4 periods. , with a washout time of 7 days between each dose
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liteda® | Active Comparator | Dasatinib 100 mg tablets Lab. Tecnofarma Colombia S.A.S. Liteda® |
|
| Sprycel® | Active Comparator | Dasatinib 100 mg tablets Lab. Bristol-Myer Squibb Sprycel® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib 100 MG | Drug | single dose of 100 mg Dasatinib tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax - Maximum Observed Concentration | Bioequivalence based on Cmax | 2 days |
| AUC0-24 - Area Under the Concentration-time Curve From Time Zero to 24 Hours Post-dose | Bioequivalence based on AUC0-24 | 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAIMED | ChÃa | Cundinamarca | Colombia |
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| Label | URL |
|---|---|
| An open-label, balanced, randomized, two treatments, two sequences, four periods, fully replicate, crossover study to evaluate the bioequivalence of Dasatinib 100 mg film-coated tablets of Abbott Laboratories versus Sprycel® (Dasatinib) 100 mg filmcoated | View source |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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Dasatinib bioequivalence study in fed condition
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randomized
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |