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RECRUITING
NCT07096869
PHASE1

Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Patients

Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

View on ClinicalTrials.gov

Summary

The main purpose of this study is to evaluate the bioequivalence of paclitaxel protein-bound particles for injectable suspension (albumin-bound) (100 mg, test product) and Abraxane® (100 mg, reference product) in breast cancer patients.

Official title: A Randomized, Open-Label, Two-Period, Crossover Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) and Abraxane® in Breast Cancer Patients

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2025-06-26

Completion Date

2026-02-25

Last Updated

2025-07-31

Healthy Volunteers

No

Conditions

Interventions

DRUG

Paclitaxel protein-bound particles for injectable suspension (albumin-bound)

IV infusion, 260 mg/m\^2

DRUG

Abraxane®

IV infusion, 260 mg/m\^2

Locations (1)

The First Hospital of Jilin University

Changchun, Jilin, China