Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Doxorubicin Hydrochloride Liposome Injection
Doxorubicin Liposome · 1 trial · 1 indication
The study end point will use PK parameter ( Cmax ) for free doxorubicin and liposome encapsulated doxorubicin
The study endpoint will use the PK parameter ( AUC 0-t) for free doxorubicin and liposome encapsulated doxorubicin ( AUC 0-t)
The study endpoint will use the PK parameter ( AUC 0-Inf) for free doxorubicin and liposome encapsulated doxorubicin
| Arm | Type | Description |
|---|---|---|
| Test Product - T | EXPERIMENTAL | doxorubicin hydrochloride liposome ( Dr. Reddy's Lab ) Use the test drug (doxorubicin hydrochloride liposome Injection 20mg/10mL i.e. 2mg/mL from Dr.Reddy's Laboratories Ltd., India) ; then use the reference drug ( doxorubicin hydrochloride liposome Injection 20mg/10mL i.e. 2mg/mL from Sun Pharma ) after at least 4-weeks. |
| Reference Product - R | ACTIVE_COMPARATOR | doxorubicin hydrochloride liposome ( Sun Pharma ) Use the reference drug (doxorubicin Hydrochloride Liposome Injection 20mg/10mL i.e. 2mg/mL; from Sun Pharma ) ; then use the test drug ( doxorubicin hydrochloride liposome Injection 20mg/10mL i.e. 2mg/mL from Dr.Reddy's Laboratories Ltd., India) after at least 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Doxorubicin Hydrochloride Liposome Injection | DRUG | 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. |
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...