The aim of this study is to demonstrate the bioequivalence of DOXIL/CAELYX, 40 mg/m2 (IV infusion over 90 minutes) between two manufacturing facilities. According to the Food and Drug Administration (FDA), two products are considered to be bioequivalent when they are equal in the rate and extent to which the active pharmaceutical ingredient (API) becomes available at the site(s) of drug action. Any abnormalities of the safety endpoints (Clinical Laboratory Test, Electrocardiogram, Left Ventricular Ejection Fraction, Physical Examination) will be captured as Adverse Events.
Age range
18 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Cmax based on encapsulated doxorubicin in patients
Timeframe: Day 1 (Cycle 1) and Day 28 (Cycle 2) at 15 minutes (min) prior to dosing as a baseline measurement and at 15 min, 30 min, 1 hour (h), 1 h 30 min, 1 h 35 min, 1h 45 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 96 h, 168 h, 240 h, 336 h, 504 h post-dosing
AUC0-t based on encapsulated doxorubicin in patients
Timeframe: Day 1 (Cycle 1) and Day 28 (Cycle 2) at 15 minutes (min) prior to dosing as a baseline measurement and at 15 min, 30 min, 1 hour (h), 1 h 30 min, 1 h 35 min, 1h 45 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 96 h, 168 h, 240 h, 336 h, 504 h post-dosing
AUC0-∞ based on encapsulated doxorubicin in patients
Timeframe: Day 1 (Cycle 1) and Day 28 (Cycle 2) at 15 minutes (min) prior to dosing as a baseline measurement and at 15 min, 30 min, 1 hour (h), 1 h 30 min, 1 h 35 min, 1h 45 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 96 h, 168 h, 240 h, 336 h, 504 h post-dosing