Clinical Trial

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

Completed Phase 1
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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.
Trial Details
NCT Number NCT07648940
Lead Sponsor Zodiac Produtos Farmaceuticos S.A.
Conditions Advanced Ovarian Cancer, Metastatic Breast Cancer
Enrollment 74 participants
Start Date 2023-02-13
Primary Completion 2023-06-22 (estimated)
Study Completion 2023-06-22 (estimated)
Updated on ClinicalTrials.gov 2026-06-15