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Study on Human Bioequivalence of Triprerelin Acetate for Injection

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 12, 2024 (before its estimated September 4, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
To investigate the pharmacokinetics of triprerelin acetate for injection and triprerelin acetate (Dufferin ®) for injection of reference preparation in patients with prostate cancer by single intramusculodynamic injection in fasting state, and to evaluate the bioequivalence of the two formulations in fasting state.
Trial Details
NCT Number NCT06683066
Lead Sponsor The Affiliated Hospital of Qingdao University
Collaborators: Shandong Cancer Hospital and Institute, Hunan Cancer Hospital, Shanxi Province Cancer Hospital, The First Affiliated Hospital of Shanxi Medical University, The Second Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Chengdu Medical College, Zibo Central Hospital, Yuncheng Central Hospital, Yichang Central People's Hospital
Conditions
(from sponsor)		 Prostate Cancer (CRPC)
Related terms Prostatic Neoplasms
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov