Title
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 1Lead Sponsor
SPARCStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Breast Cancer and Ovarian CancerIntervention/Treatment
doxorubicin ...Study Participants
29This 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.
2 mg/ml intravenous infusion
2 mg/ml intravenous infusion
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