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Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection (Lipodox®) in Chinese Patients

NCT05273944 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-03-10

No results posted yet for this study

Summary

Bioequivalence study is proposed to be carried out on patients of breast cancer/ ovarian cancer, who are administrated for Doxorubicin Hydrochloride Liposomal Injection Lipodox® or Caelyx® in a dose of 50 mg/m2.

Conditions

Interventions

DRUG

Doxorubicin Hydrochloride Liposome Injection

50mg/m2, intravenous drip on Day 1 of each cycle. On Day 1 of Cycle 1 patients will receive either reference or test product. On Day 1 of Cycle 2, patients will crossover to the alternate reference or test formulation. To measure pharmacokinetic paratemers of Caelyx® versus Lipodox®.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • Hunan Cancer Hospital

    collaborator OTHER

  • The Second Affiliated Hospital of Chongqing Medical University

    collaborator OTHER

  • First Affiliated Hospital of Jinan University

    collaborator OTHER

  • Zhejiang Provincial People's Hospital

    collaborator OTHER

  • Yuncheng Central Hospital

    collaborator OTHER

  • Shantou Central Hospital

    collaborator OTHER

  • Yuebei People's Hospital

    collaborator OTHER

  • Cancer Hospital of Guizhou Province

    collaborator OTHER

  • Guangzhou Panyu Central Hospital

    collaborator OTHER

  • Dongguan People's Hospital

    collaborator OTHER_GOV

  • Shenzhen Kangzhe Pharmaceutical 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
2021-07-28
Primary Completion
2022-03-31
Completion
2022-04-30

Countries

  • China

Study Locations

More Related Trials

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 NCT05273944 on ClinicalTrials.gov