Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection

PHASE1CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

April 30, 2015

Study Completion Date

August 31, 2015

Conditions
Ovarian Epithelial Cancer Recurrent
Interventions
DRUG

Doxorubicin Hydrochloride Liposome Injection

50mg/m2, IV on Day 1 of each cycle, On Day 1 of Cycle 2 , patients will crossover to the alternate reference or test formulation , After completion of Cycle 2 ( Day 28) , patients will be continued on the treatment of Doxorubicin Hydrochloride Liposome injection upto 4 more cycles if tolerance permits under guidance of their attending physicians.

Trial Locations (11)

500034

Bibi General Hospital, Hyderabad

Unknown

City Cancer Center, Vijaywada

Nirmal Hospital Pvt Ltd, Surat

Srinivasam Cancer Care Hospitals India Private Limited, Bangalore

Erode Cancer Center, Erode

Cancer Clinic and Nursing Home & Jasleen Hospital, Nagpur

Curie Manavta Cancer Centre, Nashik

Acharya HariHar Regional Cancer Centre, Cuttack

Meenakshi Mission Hospital & Research Centre, Madurai

Dr. G. Viswanathan Speciality Hospitals, Trichy

MNJ Institute of Oncology & Regional Cancer Centre, Hyderabad

All Listed Sponsors
lead

Dr. Reddy's Laboratories Limited

INDUSTRY