Study on Human Bioequivalence of Triprerelin Acetate for Injection
ConditionProstate Cancer (CRPC)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorThe Affiliated Hospital of Qingdao University
About this trial
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
None
Trial design
Treatments tested in this trial
- Triprorelin for injection
- Diphereline
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
The Affiliated Hospital of Qingdao University
Lead sponsor
Shandong Cancer Hospital and Institute
Collaborator
Hunan Cancer Hospital
Collaborator
Shanxi Province Cancer Hospital
Collaborator
The First Affiliated Hospital of Shanxi Medical University
Collaborator
The Second Affiliated Hospital of Chongqing Medical University
Collaborator
First Affiliated Hospital of Chengdu Medical College
Collaborator
Zibo Central Hospital
Collaborator
Yuncheng Central Hospital
Collaborator
Yichang Central People's Hospital
Collaborator
Source ClinicalTrials.gov