Life sciences · Interventional Study
ClinicalTrials.gov · October 13, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06765590). This is a study registration, not published results. Lead sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 24 participants (ESTIMATED). Conditions: Breast Cancer. Interventions: DRUG: T, 260 mg/m2, paclitaxel for injection (albumin-bound); DRUG: R, 260 mg/m2, paclitaxel for injection (albumin bound).. Primary outcome measures: Maximum observed concentration of paclitaxel (Cmax) , Predose: 0 hours; Post-infusion: 0.25 hours, 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours.; Area under the concentration-time curve from time zero to infinite time of paclitaxel (AUC 0-inf) , Predose: 0 hours; Post-infusion: 0.25 hours, 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours.; Area under the concentration-time curve from time zero to the last time of paclitaxel (AUC 0-t) , Predose: 0 hours; Post-infusion: 0.25 hours, 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours. Brief 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.