WHO ICTRP trial

A SINGLE-DOSE PHARMACOKINETIC AND BIOAVAILABILITY STUDY OF A GENERIC…

PER-092-12 · Registro Peruano de Ensayos Clínicos (REPEC)

Key facts

Trial ID PER-092-12
Public title A SINGLE-DOSE PHARMACOKINETIC AND BIOAVAILABILITY STUDY OF A GENERIC LIPOSOME-ENCAPSULATED DOXORUBICIN HYDROCHLORIDE FORMULATION IN SUBJECTS WITH EPITHELIAL OVARIAN CARCINOMA WHO HAVE FAILED PLATINUM-BASED CHEMOTHERAPY
Scientific title A SINGLE-DOSE PHARMACOKINETIC AND BIOAVAILABILITY STUDY OF A GENERIC LIPOSOME-ENCAPSULATED DOXORUBICIN HYDROCHLORIDE FORMULATION IN SUBJECTS WITH EPITHELIAL OVARIAN CARCINOMA WHO HAVE FAILED PLATINUM-BASED CHEMOTHERAPY
Primary sponsor TOLMAR Inc,
Registry Registro Peruano de Ensayos Clínicos (REPEC)
Study type Interventional
Phase IV
Interventions THIS STUDY IS DESIGNED TO EVALUATE THE BA, PK, AND SAFETY OF TOLMAR FORMULATION AT THE DOXIL STANDARD DOSE OF 50 MG/M2. AN ESTIMATE OF THE RELATIVE BA (IE, AREA UNDER THE PLASMA CONCENTRATION-TIME CURVE [AUC] OF INVESTIGATIONAL PRODUCT…
Registration date Feb 21, 2013
Target size 26
Registry page ins.gob.pe

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