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Bioequivalence of (cytarabine: daunorubicin) liposome vs Vyxeos in elderly AML
NCT05801835Recruiting
- Sponsor
- CSPC Zhongnuo Pharmaceutical
- Start
- Aug 2023
- Primary completion
- Apr 2025
- Modality
- Targeted Liposomes, Stealth (PEGylated) Liposomes, Conventional Liposomes
- Countries
- 1
01
Overview
Randomised, open-label trial of daunorubicin + cytarabine liposome in acute myeloid leukemia (AML) (2 arms), sponsored by CSPC Zhongnuo Pharmaceutical. Primary endpoints: Maximum (peak) plasma drug concentration (Cmax) of daunorubicin cytarabine liposomes and Area under the plasma concentration versus time curve calculated from 0 to 48h post administration (AUC0-48h) of daunorubicin cytarabine liposomes. Started Aug 2023; status: recruiting.
02
Drugs
daunorubicin + cytarabine liposome
03
Conditions
acute myeloid leukemia (AML)
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