A multicenter, open label, randomized, balanced, two treatment, two period, two sequence, two way crossover, single dose, bioequivalence study of Doxorubicin Hydrochloride Liposome Injection20mg/10mL of Mylan Laboratories Ltd India with Doxorubicin Hydrochloride Liposome injection for intravenous infusion20mg/10mlManufactured by SUN pharmaceutical Ind Ltd Halol Baroda Highway halol 389350 Gujarat India administered in female patients with ovarian cancer whose disease has progressed or recurred after platinum based chemotherapy under fed condition.

Mylan Laboratories Limited0 个研究点目标入组 125 人开始时间: 待定最近更新: 2022年10月17日

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•1 Non-smoker, female, having a Body Mass Index (BMI) atleast 17
•2 Patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start Doxorubicin Hydrochloride liposomal injection.
•3 Patients with life expectancy of at least 3 months.
•4 Adequate hemopoeitic, renal and liver function.
•5 Sexually active women, unless surgically sterile or postmenopausal.

•1 History of allergy or hypersensitivity reactions to Doxorubicin Hydrochloride or the components of Doxorubicin Hydrochloride Liposome Injection or any related compound at any dose or other anthracycline drugs, or granisetron or dexamethasone.
•2 Patients who require a dose reduction to below 50mg/m2.
•3 Prior history of acute infusion related reaction.
•4 Prior Doxorubicin exposure that would result in a total lifetime exposure of 550 mg/m2 or more after four cycles of treatment.
•5 Patient having active opportunistic infection or other clinically significant infection
•6 Patients with history of other clinically significant concomitant disease.
•7 Participation in another clinical trial within 60 days prior to first day of dosing of Investigational Medicinal Product.
•8 Pregnant or breastfeeding female.
•9 Patients with any cardiac risks.
•10 Patients with hepatic impairment and severe renal impairment.
•11 A positive HIV and hepatitis screen.
•12 Donation of blood within 90 days prior to receiving the first dose of Investigational Medicinal Product for the current study.

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