NCT04920500

Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients

A Randomized, Double-blind, Multiple-Dose, Two-Cycle, Parallel-Group, Bioequivalence Pretrial of Daunorubicin Cytarabine Liposome for Injection in Older, Naive AML Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
• Sex: All
• Age: 55 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Double-blind, Multiple-Dose, Two-Cycle, Parallel-Group, Bioequivalence pretrial of Daunorubicin Cytarabine liposome for Injection in older, naive patients with Acute Myeloid Leukemia (AML).

Detailed description

Bioequivalence Study of Daunorubicin Cytarabine liposome for injection, 100 units (CHINO Pharmaceutical Group Shijiazhuang Pharmaceutical Co Ltd), versus Vyxeos®, 100 units (Jazz Pharmaceuticals Public Limited Company), in patients with AML .

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Daunorubicin Cytarabine liposome for injection	Induction 1: \[100 U/m²\] i.v. d1,3,5 Induction 2: \[100 U/m²\] i.v. d1,3
DRUG	Vyxeos、Daunorubicin Cytarabine liposome for injection	Induction 1: \[100 U/m²\] i.v. Vyxeos（d1）,Daunorubicin Cytarabine liposome for injection（d3、d5） Induction 2: \[100 U/m²\] i.v. Daunorubicin Cytarabine liposome for injection（d1、d3 ）

Timeline

• Start date: 2020-09-04
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2021-06-09
• Last updated: 2021-06-09

Locations

1 site across 1 country: China