patient with prostate cancer.
Conditions
Interventions
Intervention 1: Intervention group: Triptorelin SR Depot Powder for IM Injection 3.75 mg of The Test (Homa Pharmed, Iran) as a test. Intervention 2: Intervention group: (DIPHERELINE® SR. 3.75 mg Powde
Sponsors
Homa Pharmed Pharmaceutical company
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: male patient with prostate cancer Informed consent form Age between18-55 Body mass index range (18-30) weight =50.0kg who had not received gonadotropin-releasing hormone analogues (GnRHa); Patients receiving stable treatment with Triptorelin acetate for injection Patients who have previously been treated with a gonadotropin-releasing hormone analogue (GnRHa) and who have been evaluated by the investigators as suitable for treatment with GNRHA;
Exclusion criteria
Exclusion criteria: Smoking Alcohol and drug abuse Abnormal liver or kidney function AIDS, HBV, HCV, syphilis History of acute or chronic GI, liver, kidney, or cardiovascular disease Concurrent malignant tumors other than prostate cancer within 5 years, excluding basal cell carcinoma or squamous cell carcinoma of the skin that has been surgically removed;
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time. | — |
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of the drug. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours and the morning of days 2, 4, 8, 15, 22, 29, 36 and 42 after drug administration. Method of measurement: Liquid Chromatography Mass-Mass. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactJavad Shokri
Tabriz University of Medical Sciences
Outcome results
None listed