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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Triprorelin for injection
DrugSpecification: Triprorelin for injection 3.75mg. Produced and supplied by Qilu Pharmaceutical Co.
Diphereline
DrugSpecification: Diphereline 3.75mg. Produced by Ipsen Pharma Biotech and supplied by Qilu Pharmaceutical Co.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Group AExperimental treatment 1 intervention
Group B: Group BActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Time frame
672 hours2
Area under the plasma concentration versus time curve (AUC0-28d)
Area under the drug concentration-time curve from time 0 to the 28d accurately measurable concentration at sample collection time
Time frame
28 days3
Area under the plasma concentration versus time curve (AUC7-28d)
Area under the drug concentration-time curve from time 7 to 28d accurately measurable concentration at sample collection time
Time frame
28 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
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