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Clinical Trial Summary

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.


Clinical Trial Description

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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03109249
Study type Interventional
Source Sun Pharma Advanced Research Company Limited
Contact
Status Completed
Phase Phase 1
Start date January 14, 2017
Completion date October 4, 2018

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