NCT04460820

A Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection

A Randomized,Open-label, Single-Dose,Two-Cycle,Crossover Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection Under Advanced Breast Cancers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Randomized,Open-label, Single-Dose,Two-Cycle,Cross- Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection Under Advanced Breast Cancers.

Detailed description

Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection , 20 mg:10 mL (CSPC OuYi Pharmaceutical Technology Co, Ltd), and Caelyx®, 20 mg:10 mL (Janssen-Cilag International NV), in Advanced Breast Cancers.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Doxorubicin Hydrochloride Liposome Injection	50mg/m2,IV on Day 1 of each cycle

Timeline

• Start date: 2019-07-04
• Primary completion: 2019-12-23
• Completion: 2019-12-23
• First posted: 2020-07-08
• Last updated: 2020-07-08

Locations

1 site across 1 country: China