NCT05273944

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

A Randomized, Open-label, Single-dose, Two-preparation, Two-sequence, Two-cycle Crossover, Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection in Patients With Breast Cancer/Ovarian Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shenzhen Kangzhe Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a randomized, open-label, single-dose, two-preparation, two-sequence, two-cycle crossover bioequivalence study. This study will be conducted in female subjects aged 18 to 75 years diagnosed with breast cancer/ ovarian cancer. Each subject will be randomized to two treatment sequences (RT or TR) with equal numbers of patients according to a randomization scheme prepared to start of the trial. The cleaning period was 28-42 days. Serial blood samples for determination of free and liposomal encapsulated doxorubicin plasma concentration for PK analysis will be obtained in each cycle. Blood samples to be obtained at 0 h (within 60 min) before infusion, 15 min, 30 min, 45 min, 60 min, 75 min, 90min after the beginning of infusion, 15 min, 30 min, 1.0 h, 3.0 h, 5.0 h, 8.0 h, 16.0 h, 24.0 h, 36.0 h, 48.0 h, 96.0 h, 168.0 h, 240.0 h, 336.0 h after infusion completed.

Conditions

• Breast Cancer
• Ovarian Cancer

Interventions

Type	Name	Description
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®.

Timeline

• Start date: 2021-07-28
• Primary completion: 2022-03-31
• Completion: 2022-04-30
• First posted: 2022-03-10
• Last updated: 2022-03-10

Locations

1 site across 1 country: China