A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection in Patients With Ovarian Cancer
Summary
This study is planned with the objective of evaluating the bioequivalence of two liposomal formulations of Doxorubicin hydrochloride injection in patients with ovarian cancer in addition to monitoring safety. Blood samples will be collected at specific timepoints during the study.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Conditions
Ovarian Carcinoma
Intervention
Liposomal Doxorubicin Hydrochloride, Liposomal Doxorubicin Hydrochloride Injection
Location
MNJ Institute of Oncology & Regional Cancer Center
Hyderabaad
Andhra Pradesh
India
500004
Status
Not yet recruiting
Source
Sun Pharma Advanced Research Company Limited
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00862355
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Doxorubicin
Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN.
Epirubicin
An anthracycline which is the 4'-epi-isomer of doxorubicin. The compound exerts its antitumor effects by interference with the synthesis and function of DNA.
Naphthylvinylpyridine
4(1-Naphthylvinyl)pyridine hydrochloride. Cholinesterase inhibitor. Synonym: YuB 25.
Tetramethylphenylenediamine
Used in the form of the hydrochloride as a reagent in ANALYTICAL CHEMISTRY TECHNIQUES.
Ambroxol
A metabolite of BROMHEXINE that stimulates mucociliary action and clears the air passages in the respiratory tract. It is usually administered as the hydrochloride.
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