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

NCT07096869 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-07-31

No results posted yet for this study

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.

Conditions

  • Bioequivalence

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

Sponsors & Collaborators

  • CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-26
Primary Completion
2025-12-31
Completion
2026-02-25

Countries

  • China

Study Locations

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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 NCT07096869 on ClinicalTrials.gov