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SPARC1613 is chemotherapeutic agent with a wide spectrum of anti-tumor activity. It is used extensively in the treatment of advanced carcinomas of the breast, ovaries, lung, and other solid tumors.This is pharmacokinetic study of SPARC1613 and Reference1613.
The purpose of this study is to evaluate level of test medication with respect to time in the body, and safety when compared with the reference medication Subject will be randomly assigned to receive an intravenous infusion of either SPARC1613 delivered over 25 (±1) minutes or Reference1613 delivered over 30 (±1) minutes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPARC1613 | Experimental | Intravenous administration of SPARC1613 |
|
| Reference 1613 | Active Comparator | Intravenous administration of Reference1613 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPARC1613 | Drug | Single intravenous infusion of 260 mg/m2 of SPARC1613 delivered over 25 minutes in either of two periods (Period 1 or 2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Pre-dose,post dose upto 3 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events encountered following dosing with SPARC1613 and Reference1613 will be recorded as per CTCAE4.03 | First dose of trial drug to one month after last dose. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPARC Site 40 | Visakhapatnam | Andhra Pradesh | 530017 | India | ||
| SPARC Site 20 |
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| Reference1613 | Drug | Single intravenous infusion of 260 mg/m2 of Reference1613 delivered over 30 minutes in either of two periods (Period 1 or 2) |
|
| Ahmedabad |
| Gujarat |
| 380052 |
| India |
| SPARC site 39 | Ahmedabad | Gujarat | 380060 | India |
| SPARC site 38 | Karamsad | Gujarat | 388325 | India |
| SPARC Site 27 | Surat | Gujarat | 395002 | India |
| SPARC Site 35 | Surat | Gujarat | 422005 | India |
| SPARC Site 24 | Vadodara | Gujarat | 391760 | India |
| SPARC Site 13 | Bangalore | Karnataka | 560027 | India |
| SPARC site 41 | Bangalore | Karnataka | 560072 | India |
| SPARC Site 28 | Bangalore | Karnataka | 560090 | India |
| SPARC Site 22 | Belagavi | Karnataka | 590010 | India |
| SPARC Site 7 | Mangalore | Karnataka | 5750001 | India |
| SPARC Site 25 | Aurangabad | Maharashtra | 431 003 | India |
| SPARC Site 23 | Aurangabad | Maharashtra | 431210 | India |
| SPARC Site 2 | Mumbai | Maharashtra | 400022 | India |
| SPARC Site 12 | Nagpur | Maharashtra | 440003 | India |
| SPARC site 34 | Nashik | Maharashtra | 422004 | India |
| SPARC Site 37 | Nashik | Maharashtra | 422005 | India |
| SPARC Site 18 | Pune | Maharashtra | 411 044 | India |
| SPARC Site 4 | Pune | Maharashtra | 411004 | India |
| SPARC Site 9 | Aurangabad | Marashtra | 431005 | India |
| SPARC Site 15 | Khordha | Odisha | 751007 | India |
| SPARC site 42 | Chennai | Tamil Nadu | DrGRaja | India |
| SPARC Site 32 | Madurai | Tamil Nadu | 625107 | India |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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