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Comparing the Pharmacokinetic Profile of LY01612 and CAELYX® in Chinese Subjects With Advanced Breast Cancer

NCT06098599 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-10-24

No results posted yet for this study

Summary

A multicenter, randomized, open-lable, single-dose, two-cycle, double-cross bioequivalence study comparing the pharmacokinetic profile of LY01612 (Doxorubicin hydrochloride liposome injection) and CAELYX® in Chinese subjects with advanced breast cancer

Conditions

Interventions

DRUG

Doxorubicin hydrochloride liposome injection

Doxorubicin hydrochloride liposome injection was administered intravenously for 90min (±3min) with an infusion pump on day 1 and day 29 of the trial. Doxorubicin hydrochloride liposome injection was diluted with 250mL 5% glucose injection.

Sponsors & Collaborators

  • Luye Pharma Group 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
2022-05-17
Primary Completion
2023-02-09
Completion
2023-02-09

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 NCT06098599 on ClinicalTrials.gov