NCT06765590

Bioequivalence Study of Paclitaxel for Injection (Albumin Bound) in Subjects With Breast Cancer

A Randomized, Open-label, Single-dose, Two-period, Two-way Crossover Bioequivalence Study of Paclitaxel for Injection (Albumin Bound) in Subjects With Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study was a multicenter, randomized, open, single-dose, two-cycle, two-cross-dosing human bioequivalence trial designed to evaluate the bioequivalence of tested and reference preparations in breast cancer subjects.

Detailed description

This study was a multicenter, randomized, open, single-dose, two-cycle, two-cross-dosing human bioequivalence trial designed to evaluate the bioequivalence of tested and reference preparations in breast cancer subjects.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	T, 260 mg/m2, paclitaxel for injection (albumin-bound)	T, 260 mg/m2, paclitaxel for injection (albumin-bound)
DRUG	R, 260 mg/m2, paclitaxel for injection (albumin bound).	R, 260 mg/m2, paclitaxel for injection (albumin bound).

Timeline

• Start date: 2025-03-12
• Primary completion: 2026-06-12
• Completion: 2026-10-30
• First posted: 2025-01-09
• Last updated: 2026-03-09

Locations

1 site across 1 country: China