Single-Blinded Study to Compare the Pharmacokinetic, Pharmacodynamic, and Safety of Goserelin Acetate Injection with Reference Drug Zoladex® Injection (Manufactured by AstraZeneca UK, Registered by AstraZeneca Republic of Korea) in Male Patients with Prostate Cancer – Preliminary Study

Tahapan Penelitian : Recruit
Sponsor:
Mitra Pelaksana:
Not Specified
No Registry
INA-4ZFOL7AT
Tanggal Input Registry : 25-03-2025

19-02-2025
To evaluate the pharmacokinetics profile of the Goserelin Acetate Injection compared to Zoladex® Injection (AstraZeneca, Republic of Korea) after a single injection.
To evaluate the pharmacodynamics of the Goserelin Acetate Injection compared to the Zoladex® Injection (AstraZeneca, Republic of Korea) after a single injection. To evaluate safety after a single injection of investigational product.
 
Single-Blinded Study to Compare the Pharmacokinetic, Pharmacodynamic, and Safety of Goserelin Acetate Injection with Reference Drug Zoladex® Injection (Manufactured by AstraZeneca UK, Registered by AstraZeneca Republic of Korea) in Male Patients with Prostate Cancer – Preliminary Study
Single-Blinded Study to Compare the Pharmacokinetic, Pharmacodynamic, and Safety of Goserelin Acetate Injection with Reference Drug Zoladex® Injection (Manufactured by AstraZeneca UK, Registered by AstraZeneca Republic of Korea) in Male Patients with Prostate Cancer – Preliminary Study
Interventional
Goserelin Acetate Injection
24
 

Inclusion Criteria:

Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study, Aged 19 years (inclusive) or above, Male subject diagnosed by confirmation of prostate cancer of any stages, for whom endocrine treatment is indicated, must have had their diagnosis confirmed before screening by one of the following methods: a Digital Rectal Exam (DRE) showing abnormalities and/or a PSA test with a level ≥ 4 ng/mL as an initial indicator of prostate cancer, Subject with laboratory evidence of biochemical recurrence (BCR) are allowed. BCR is defined as the presence of prostate-specific antigen (PSA) greater than 0.2 ng/ml measured 6 to 13 weeks after radical prostatectomy followed by a confirmatory test showing persistent PSA greater than 0.2 ng/mL; or “PSA nadir + 2 ng/mL” (treated with radiation therapy”; or PSA doubling time < 6 months without radiographic evidence of recurrence, Subject with a screening testosterone level >1.5 ng/mL, Body mass index between 18.5 and 29.9 kg/m2, inclusive, Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2, Normal Bone Mineral Density (BMD), defined as T-score ≥ -1.0, Willing to practice abstention or non-hormonal contraception during the study,

Exclusion Criteria:

Subject already on GnRH receptor agonist or antagonist therapy directed for prostate cancer, Subject who have previously failed on GnRH receptor agonist or antagonist therapy for prostate cancer, Scheduled for prostatectomy or radiotherapy during study period and within 6 months from inclusion, Subjects receiving 5-alpha reductase inhibitor therapy such as finasteride or dutasteride Subject at risk of urinary tract obstruction or spinal cord compression due to potential testosterone surge, History or presence of relevant liver disease or hepatic dysfunction (laboratory result for AST or ALT ≥ 2 ULN), Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV, History or presence of renal failure or renal dysfunction, defined as any clinically diagnosed significant renal impairment, such as chronic kidney disease (CKD) stage 3 or higher, and based on a clinically significant renal function laboratory test (serum creatinine ≥1.5 mg/dL), Any major illness in the past 90 days other than prostate cancer, Have unstable clinically significant ongoing chronic medical illness or malignancy that could confound interpretation of the study at investigator discretion, Subject with history of severe uncontrolled asthma, anaphylactic reactions, defined as severe and frequent exacerbations requiring hospitalization, and oral corticosteroid use, Subjects with uncontrolled diabetes mellitus, defined as those requiring insulin for unstable hyperglycemia or with fasting blood glucose ≥ 126 mg/dL, Subjects with history of severe urticaria and/or angioedema, Participation in any clinical trial within the past 90 days calculated from the last visit until this study’s first dosing day, Report a history of drug or alcohol addiction or abuse within the past 12 months prior to screening for this study, Subject with positive urine screening for drug or alcohol abuse, Subject who are taking medication for seizures or oral steroids such as dexamethasone, methylprednisolone or prednisone, Subject with known risk factors for Torsade de Pointes by ECG at screening of with QTc > 450ms or have a family history of prolonged QT syndrome, Subjects who have donated blood within 90 days prior to the study, experienced significant blood loss within 90 days before screening, or have a history of coagulation disorders Subject with abnormal laboratory results which in the judgment of the investigator would affect the subject’s health or the outcome of the trial. Any known allergy or intolerance to any of the ingredients contained in products. Any history of clinical significant allergies including food or drug allergies. Unwilling and unable to attend the scheduled study visits and comply with the study procedures.
 
1113/KEPK/X/2024
Not applicable
PPUK/PPUB number
Vicky Achmad Ginanjar