Actively Recruiting
Study on Human Bioequivalence of Triprerelin Acetate for Injection
Led by The Affiliated Hospital of Qingdao University · Updated on 2024-11-12
120
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
T
The Affiliated Hospital of Qingdao University
Lead Sponsor
S
Shandong Cancer Hospital and Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study on Human Bioequivalence of Triprerelin Acetate for Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 years and older
- Male weight 50.0kg or more
- Body mass index (BMI) between 19 and 30 kg/m2
- Histopathologically diagnosed prostate cancer suitable for endocrine therapy
- Patients who have not received or are receiving stable treatment with triprerelin acetate for injection
- ECOG performance status score of 2 or less
- Expected survival of 9 months or more
- Adequate hematopoietic, liver, and kidney function
- Willingness to use non-drug contraceptive methods for 6 months after signing consent
You will not qualify if you...
- Previous surgical castration
- Known or suspected signs and symptoms of BMS (Bone Marrow Suppression) or definite diagnosis of BMS
- Other malignant tumors within 5 years except certain skin cancers surgically removed
- Previous adrenalectomy, pituitary resection, or pituitary disease
- Planned prostate surgery or major surgery during study period (except urinary tract obstruction removal)
- History or risk of spinal cord compression or urinary tract obstruction causing kidney injury
- Severe cardiovascular or cerebrovascular diseases including poorly controlled hypertension, recent myocardial infarction, severe heart failure, uncontrolled arrhythmia, or congenital long QT syndrome
- Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c >8.0% at screening)
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- History of severe asthma, anaphylaxis, urticaria, or vasogenic edema
- Allergy to triprerelin acetate or GnRH analogues
- Current abuse of drugs or alcohol exceeding defined limits
- Use of drugs known to prolong QT interval within 4 weeks prior to dosing
- Participation in other clinical trials within 1 month prior to dosing
- Receipt of any vaccine within 4 weeks prior to dosing
- Consumption of special diets (grapefruit, pomelo) within 48 hours prior to dosing
- Blood donation or significant blood loss within 1 month prior to dosing
- Difficulty with venous blood collection
- Other conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266003
Actively Recruiting
Research Team
Y
Yu Cao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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