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.

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.

Inclusion Criteria:

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

Exclusion Criteria:

1. Females who were pregnant, breastfeeding, or are likely to become pregnant
2. Subjects who had any medical condition (except metastatic breast cancer/advanced ovarian cancer) that could jeopardize their health or prejudice the results
3. Subjects deemed uncooperative or noncompliant
4. Smoking or consumption of any nicotine products