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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
142
Single intravenous infusion of 260 mg/m2 of SPARC1613 delivered over 25 minutes in either of two periods (Period 1 or 2)
Single intravenous infusion of 260 mg/m2 of Reference1613 delivered over 30 minutes in either of two periods (Period 1 or 2)
SPARC Site 40
Visakhapatnam, Andhra Pradesh, India
SPARC Site 20
Ahmedabad, Gujarat, India
Maximum observed concentration (Cmax)
Time frame: Pre-dose,post dose upto 3 days
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SPARC site 39
Ahmedabad, Gujarat, India
SPARC site 38
Karamsad, Gujarat, India
SPARC Site 27
Surat, Gujarat, India
SPARC Site 35
Surat, Gujarat, India
SPARC Site 24
Vadodara, Gujarat, India
SPARC Site 13
Bangalore, Karnataka, India
SPARC site 41
Bangalore, Karnataka, India
SPARC Site 28
Bangalore, Karnataka, India
...and 14 more locations