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A Bioequivalence Study of (Cytarabine: Daunorubicin) Liposome for Injection

NCT05801835 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-09-21

No results posted yet for this study

Summary

The purpose of this study is to determine the bioequivalence of (cytarabine: daunorubicin) liposome for injection and Vyxeos in elderly acute myeloid leukemia (AML) subjects.

Conditions

Interventions

DRUG

(cytarabine: daunorubicin) liposome for injection

Be given intravenously at 65U/m\^2 on days 1 and day3 of the first cycle of induction.

DRUG

Vyxeos

Be given intravenously at 65U/m\^2 on days 1 and day3 of the first cycle of induction.

DRUG

(cytarabine: daunorubicin) liposome for injection

Be given intravenously at 65U/m\^2 on days 1 and day3 of the second cycle of induction.

DRUG

Vyxeos

Be given intravenously at 65U/m\^2 on days 1 and day3 of the second cycle of induction.

Sponsors & Collaborators

  • CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jianxiang Wang, MD · Chinese Academy of Medical Sciences & Peking Union Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-25
Primary Completion
2025-04-30
Completion
2025-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05801835 on ClinicalTrials.gov