Study of Doxorubicin in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer
A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study Of Doxorubicin Hydrochloride Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Sun Pharma Advanced Research Company Limited, India, And Caelyx® (Doxorubicin Hydrochloride) Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Schering-Plough, Belgium, in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer, Under Fed (Normal Breakfast) Conditions.
  • Phase

    Phase 1
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    doxorubicin ...
  • Study Participants

This was a randomized, multi centre, open label, two treatment, two period, two sequence, single dose, crossover study, with at least 28 days washout between doses, conducted under fed (normal breakfast) conditions.
Study Started
Sep 03
Primary Completion
Nov 28
Study Completion
Nov 28
Last Update
Jul 23

Drug SPARC-08-038

2 mg/ml intravenous infusion

Drug Ref-08-038

2 mg/ml intravenous infusion

SPARC-08-038 Experimental

2 mg/ml

Ref-08-038 Active Comparator


Inclusion Criteria:

Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
Patients with metastatic breast cancer/advanced ovarian cancer having age within the range of between 18-55 years.
Subjects who had no evidence of underlying disease
Subjects who had signed written consent form

Exclusion Criteria:

Females who were pregnant, breastfeeding, or are likely to become pregnant
Subjects who had any medical condition (except metastatic breast cancer/advanced ovarian cancer) that could jeopardize their health or prejudice the results
Subjects deemed uncooperative or noncompliant
Smoking or consumption of any nicotine products
No Results Posted