Clinical Trial

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

Recruiting Phase 1
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Record status
This record was last updated July 31, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07096869
Lead Sponsor CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Conditions Bioequivalence
Enrollment 28 participants
Start Date 2025-06-26
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-02-25 (estimated)
Updated on ClinicalTrials.gov 2025-07-31