Assess Bioequivalence of Two Formulations of Doxorubicin Hydrochloride Liposome in Female Patients With Ovarian Cancer
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, single-dose, open-label, randomized, balanced, two-treatment,
two-cycle, two-sequence crossover study to assess bioequivalence of test (T) and reference
(R) formulations of doxorubicin hydrochloride liposome injection in female patients with
ovarian cancer.
Each patient will be randomized to one of two treatment sequences (RT or TR) according to a
randomization scheme prepared prior to the start of the trial.There will be at least 4-week
apart between each single-dose administration. Serial blood samples for determination of free
doxorubicin and liposomal encapsulated doxorubicin plasma concentrations for PK analysis will
be obtained in each cycle.
The 90% confidence intervals on the GMR(geometric mean ratio) of test to reference products
of free and liposome encapsulated doxorubicin for PK must be within 80-125% to demonstrate
bioequivalence.