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

NCT06765590 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-09

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • The First Hospital of Jilin University

    collaborator OTHER

  • The First Affiliated Hospital of Bengbu Medical University

    collaborator OTHER

  • Chongqing Traditional Chinese Medicine Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Henan University of Science and Technology

    collaborator OTHER

  • Qianfoshan Hospital

    collaborator OTHER

  • Sichuan Huiyu Pharmaceutical 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
2025-03-12
Primary Completion
2026-06-12
Completion
2026-10-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06765590 on ClinicalTrials.gov