A Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection
NCT04460820 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2020-07-08
Summary
A Randomized,Open-label, Single-Dose,Two-Cycle,Cross- Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection Under Advanced Breast Cancers.
Conditions
- Bioequivalence
Interventions
- DRUG
-
Doxorubicin Hydrochloride Liposome Injection
50mg/m2,IV on Day 1 of each cycle
Sponsors & Collaborators
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-04
- Primary Completion
- 2019-12-23
- Completion
- 2019-12-23
Countries
- China
Study Locations
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