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drugset / Trial / NCT06098599

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

NCT06098599 ↗

Phase 1 Completed 48 enrolled Luye Pharma Group Ltd.
RandomizedCrossoverOpen-labelTreatment

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

Timeline

Start
2022-05-17
Primary completion
2023-02-09
Completion
2023-02-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified 50 mg/m2 Intravenous

Indications

female breast carcinoma