Prostate cancer Premenopausal breast cancer Central precocious puberty
Conditions
Interventions
Control Group R:Single subcutaneous injection of the reference formulation (R), Inj. Triptorelin Acetate Microspheres (11.25 mg)
Experimental Group T:Single subcutaneous injection of the test formulation (T) triptorelin acetate microspheres for injection (11.25 mg)
Sponsors
Yuncheng Central Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must fully understand the purpose, nature, methods of the trial and possible adverse reactions, volunteer to participate as a subject, and sign an informed consent form; 2. Subjects should be able to communicate effectively with researchers and complete the trial according to the protocol requirements; 3. Age 18 years old (including the threshold value) or above; 4. Prostate cancer diagnosis: histopathologically confirmed prostate cancer, suitable for endocrine therapy, and meets one of the following two conditions: (1) Patients who have not received luteinizing hormone-releasing hormone agonist (LHRH-a) analog treatment; (2) Patients who are receiving stable subcutaneous injection of LHRH-a analog treatment; 5. Expected survival time >= 9 months; 6. Eastern Cooperative Oncology Group (ECOG) score = 1.5 × 10?/L, platelet count >= 80 × 10?/L, white blood cell count >= 3.0 × 10?/L, hemoglobin >= 80 g/L; total bilirubin = 50 mL/min [Creatinine clearance rate (male) = [(140 - age) × body weight (kg)] / [72 × creatinine concentration (mg/dL)] or = [(140 - age) × body weight (kg)] / [0.818 × creatinine (µmol/L)]].
Exclusion criteria
Exclusion criteria: 1. Patients who have undergone or are currently undergoing surgical castration for prostate cancer; 2. Patients with known or suspected symptoms, signs, or a definite diagnosis of brain metastasis or central nervous system disease; 3. Patients with other malignant tumors within 5 years, excluding basal cell carcinoma or squamous cell carcinoma of the skin that have been surgically removed; 4. Patients who have previously undergone adrenalectomy or pituitary gland removal, or those with pituitary lesions; 5. Patients who have previously undergone surgery or plan to undergo surgery during the trial period that may significantly affect drug absorption, metabolism, distribution, and excretion, as judged by the investigator; 6. Patients with a history of spinal cord compression or urinary tract obstruction causing significant kidney damage, or at risk of developing such conditions; 7. Patients with severe central nervous system diseases or a history of epilepsy, seizures, or any condition that may trigger epileptic seizures; 8. Patients with a history of interstitial pneumonia; 9. Patients with severe cardiovascular diseases, including but not limited to: a) Patients with poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg despite regular medication control); b) Patients with a history of hypertensive crisis or hypertensive encephalopathy; c) Patients who have experienced severe cardiovascular diseases within 6 months before screening, as judged by the investigator; d) Heart failure classified as grade >=II by the New York Heart Association; e) Severe arrhythmias uncontrolled by medication (including QTc interval >=450 ms), or congenital long QT syndrome; 10. Patients with type I diabetes mellitus or poorly controlled type II diabetes mellitus (glycosylated hemoglobin HbA1c >8.0% at screening); 11. Patients testing positive for hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, or syphilis spirochete antibody; 5.or active hepatitis B patients [defined as hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) >=10^4 copies or =2000 IU/mL in peripheral blood]; 12. Patients with a history of severe asthma, allergic reactions, or serious urticaria and/or angioedema; 13. Patients who are allergic to any component of the injectable triptorelin acetate microspheres or synthetic LH-RH or its derivatives, or who have an allergic constitution; 14. Patients who abuse alcohol, drugs, or screen positive for substance abuse (non-medical use of anesthetic drugs or psychotropic substances); 6.alcoholism is defined as consuming more than 14 units of alcohol per week for the 3 months prior to screening (1 unit of alcohol ˜ 360 mL of beer with 5% alcohol content or 45 mL of liquor with 40% alcohol content or 150 mL of wine with 12% alcohol content); 15. Patients who have participated in other clinical trials and used investigational drugs or devices within 3 months before screening; 16. Patients who have received attenuated live vaccines within 4 weeks before screening, or plan to receive any vaccine during the study period; 17. Patients who have received transfusions or treatments with blood components such as suspended red blood cells or platelets within 1 week before screening; 18. Subjects who do not wish to use one or more non-pharmaceutical contraceptive measures (such as barrier contraception or abstinence) during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC;Cmax;Tmax;?z;t1/2; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactZhao Fengli
Yuncheng Central Hospital
Outcome results
None listed