Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection

Inclusion Criteria:

* Female of Indian Nationality , between 18-60n years of age
* Able to understand investigational nature of this study and give written informed consent prior to the participation in the trial.
* Patients with ovarian cancer requiring Doxorubicin and whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start therapy with reference listed drug
* ECOG performance status ≤ 2
* Cardiac function ( LVEF) ≥ 50%
* patient with life expectancy of at least 3 months
* Adequate hematopoietic, renal and liver function

Exclusion Criteria:

* Prior doxorubicin exposure that would result in a total lifetime exposure of 550mg/m2 or more after four cycles of treatment .
* Pregnant or breast-feeding female
* active opportunistic infection with mycobacteria , cytomegalovirus , toxoplasma
* Impaired cardiac function including any of the following conditions within past 6 months :

  1. Unstable angina
  2. QTc prolongation or other significant ECG abnormalities
  3. Coronary artery bypass graft surgery
* History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCl or the components of Doxorubicin Hydrochloride liposome injection.
* known brain metastasis
* HIV positive antibody or syphilis
* Patients with significantly impaired hepatic function
* Clinically significant liver and kidney disease