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Bioequivalence Study of Liposomal Doxorubicin 20 mg/10 mL (Doxopeg® vs Caelyx®) in Advanced Cancer Patients

NCT07648940 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-06-15

No results posted yet for this study

Summary

To characterize the pharmacokinetic profile of pegylated liposomal doxorubicin formulations, a multicenter, randomized, two-period crossover study was conducted in 74 patients with advanced ovarian cancer or metastatic breast cancer. Blood samples were collected up to 336 hours post-dose, and plasma concentrations of encapsulated and free doxorubicin were quantified using validated LC-MS/MS methods. Pharmacokinetic parameters (Cmax, AUC0-t, AUC0-inf, tmax, t1/2, Vd, and Cl) were calculated using noncompartmental analysis.

Conditions

Interventions

DRUG

Doxopeg® - Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL)

Pegylated liposomal doxorubicin hydrochloride concentrate for solution for infusion 2 mg/mL

DRUG

Caelyx® - Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL)

Pegylated liposomal doxorubicin hydrochloride concentrate for solution for infusion 2 mg/mL

Sponsors & Collaborators

  • Zodiac Produtos Farmaceuticos S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2023-06-22
Completion
2023-06-22

Countries

  • Brazil

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 NCT07648940 on ClinicalTrials.gov