Clinical Trial

Study on Human Bioequivalence of Triprerelin Acetate for Injection

Recruiting Phase 1
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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.
Summary
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 Prostate Cancer (CRPC)
Enrollment 120 participants
Start Date 2024-12-04
Primary Completion 2025-09-04 (estimated)
Study Completion 2025-09-04 (estimated)
Updated on ClinicalTrials.gov 2024-11-12