NCT07096869

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Paclitaxel protein-bound particles for injectable suspension (albumin-bound)	IV infusion, 260 mg/m\^2
DRUG	Abraxane®	IV infusion, 260 mg/m\^2

Timeline

• Start date: 2025-06-26
• Primary completion: 2025-12-31
• Completion: 2026-02-25
• First posted: 2025-07-31
• Last updated: 2025-07-31

Locations

1 site across 1 country: China