CTRI/2024/09/074455招募中不适用
An Open-Label, Multiple Dose, Multicenter, Randomized, Two Sequence, Two-Treatment, fully Replicate, Cross-Over, Steady State, Bioequivalence Study of Test Product Leuprolide Acetate for Depot Suspension 7.5 mg of Pharmathen S.A. Greece with Reference Product Lupron Depot® 7.5 mg, Manufactured for AbbVie Inc. in Adult Male Patients with Prostate Carcinoma Undergoing Initial Therapy of Leuprolide Acetate.
Pharmathen21 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 21
- 主要终点
- To evaluate the bioequivalence between Leuprolide acetate for depot suspension 7.5 mg 1- month administration of Pharmathen S.A. Greece and Lupron Depot® 7.5 mg for 1-month administration in adult male patients with prostate carcinoma undergoing initial therapy of Leuprolide Acetate.
研究概览
简要总结
An Open-Label, Multiple Dose, Multicenter, Randomized, Two Sequence, Two-Treatment, fully Replicate, Cross-Over, Steady State, Bioequivalence Study of Test Product Leuprolide Acetate for Depot Suspension 7.5 mg of Pharmathen S.A. Greece with Reference Product Lupron Depot® 7.5 mg, Manufactured for AbbVie Inc. in Adult Male Patients with Prostate Carcinoma Undergoing Initial Therapy of Leuprolide Acetate.
Objective:
**a.**To evaluate the bioequivalence between Leuprolide acetate for depot suspension 7.5 mg for 1-month administration of Pharmathen S.A. Greece and Lupron Depot® 7.5 mg for 1-month administration in adult male patients with prostate carcinoma undergoing initial therapy of Leuprolide Acetate.
b. To evaluate the safety and tolerability of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patient will be eligible for inclusion in this study only if all of the following criteria apply:
- •Male of age 18-85 years with histologically proven carcinoma of the prostate (undergoing initial therapy of leuprolide acetate), who require leuprolide treatment as per investigator judgement.
- •Life expectancy of at least 1 year at the time of screening as judged by the investigator.
- •Patient with Body Mass Index (BMI) ≥ 18.5 to ≤ 32 kg/m2 at screening and randomization visit.
- •PSA level should be greater than 4 mg/mL.
- •Patient having adequate hematologic reserve.
- •Hemoglobin ≥ 9 gm/dL b.
- •WBC (white blood cells) ≥4000/mm3 c.
- •Absolute neutrophils count ≥1500/mm3 d.
- •Platelets ≥1,00,000/mm3 (Patient who is on coumarin anticoagulants must have Platelets count ≥1,50,000/mm3)
- •Adequate renal function at screening as defined by serum creatinine ≤ 1.6 times the ULN (Upper Limit of Normal) for the clinical laboratory.
- •Adequate and stable hepatic function as defined by bilirubin ≤ 1.5 times the ULN (upper limit of normal) and transaminases (i.e., SGOT, SGPT) ≤ 2.5 times the ULN (upper limit of normal) for the clinical laboratory at screening.
- •Note: For patient with liver metastasis, bilirubin ≤ 2 times the ULN (upper limit of normal) and transaminases (i.e., SGOT, SGPT) ≤ 5 times the ULN (upper limit of normal) is allowed.
- •Patient agrees to use acceptable contraceptive methods during study.
- •Patient with adequate muscle mass to receive the intramuscular injection according to the investigator.
- •Patient willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations.
- •Patient willing to provide informed consent to participate in the study.
- •Non-smoker or ex-smoker who has not used any nicotine containing products in the last 6 months before Day 0 of study treatment.
排除标准
- •Patient will not be eligible for inclusion in this study if any of the following criteria apply:
- •Patient with hypersensitivity to GnRH, GnRH agonist analogs including any LHRH analogues, or any excipients of the study formulation.
- •Patient with anaphylactic reactions to synthetic GnRH or GnRH agonist analogs.
- •Patient with history or presence of hypogonadism, or receipt of exogenous testosterone supplementation within 6 months of screening visit.
- •Patient requiring additional treatment for prostatic cancer (i.e. radiotherapy).
- •Participated in any other clinical investigation using experimental drug/donated blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in past 90 days before screening visit.
- •Consumption of any grapefruit juice and its products (pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices), red wine, seville oranges, and seville orange juice and its products within 07 days prior to randomization (Day 0) to throughout the study duration.
- •Patient with evidence of brain metastases, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms.
- •Patient with evidence of spinal cord compression, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms.
- •Patient with evidence of severe urinary tract obstruction with threatening urinary retention, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms.
- •Patient with excruciating, severe pain from extensive osseous deposits, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms.
- •Testosterone levels less than 1.5 ng/mL at screening and randomization visit.
- •Patient with previous orchiectomy, adrenalectomy or hypophysectomy.
- •Patient with previous prostatic surgery (e.g., radical prostatectomy, transurethral resection of the prostate [TUR-P]) within 2 weeks from screening visit or not recovered from any undesirable or harmful effects of surgery.
- •Patient with previous cancer systemic therapy such as chemotherapy, immunotherapy (e.g., antibody therapies, tumor-vaccines), biological response modifiers (e.g., cytokines) within 2 months from screening visit.
- •Patient who has received anti-androgen treatment (i.e., androgen receptor antagonist like Bicalutamide, Flutamide, Megestrol, cyproterone acetate) [No washout allowed].
- •Administration of 5-alpha-reductase inhibitors (Proscar®, Avodart®, Propecia®) within 6 months before screening visit.
- •Over-the-counter (OTC) or alternative medical therapies which have an estrogenic or antiandrogenic effect (i.e., PC-SPES, saw palmetto, Glycyrrhiza®, Urinozinc®, dehydroepiandrosterone [DHEA]) within the 3 months before randomization visit.
- •Patient with co-existent malignancy, according to the Investigators opinion.
- •Patient with abnormal or prolonged QTc interval (Bazetts formula greater than 450 msec, Appendix II), uncontrolled congestive heart failure, myocardial infarction or a coronary vascular procedure (e.g. balloon angioplasty, coronary artery bypass graft) or significant symptomatic cardiovascular disease(s) within 6 months before check-in resting uncontrolled hypertension (≥ 160/100 mmHg) or symptomatic hypotension within 3 months before randomization visit.
- •Patient with venous thrombosis within 6 months from randomization visit.
- •Patient with Insulin-dependent diabetes mellitus or uncontrolled type 2 diabetes mellitus (HbA1c greater than 7 percentage).
- •History of difficulty with donating blood or difficulty in accessibility of veins.
- •Patient who is institutionalized.
- •A positive test result for Hepatitis (includes subtypes B and C) or HIV.
- •Patient with history of drug and/or alcohol abuse within 6 months from randomization visit.
- •Patient with serious concomitant illness(es) or disease(s) [e.g., hematological, renal, hepatic, respiratory, endocrine, psychiatric] that may interfere with, or put patients at additional risk for, their ability to receive the treatment outlined in the protocol.
- •Patient receiving anticoagulants who have prothrombin and partial thromboplastin times outside of the normal range for the laboratory assays; patients who are on anticoagulation or antiplatelet medications (e.g. dipyridamole, ticlopidine, warfarin derivatives) who are not receiving a stable dose for 3 months before randomization visit; patients who are receiving warfarin-derivative anticoagulants who do not have an International Normalized Ratio (INR) in the therapeutic range for the clinical indication for which the anticoagulant has been prescribed.
- •Any other condition that, in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
结局指标
主要结局
To evaluate the bioequivalence between Leuprolide acetate for depot suspension 7.5 mg 1- month administration of Pharmathen S.A. Greece and Lupron Depot® 7.5 mg for 1-month administration in adult male patients with prostate carcinoma undergoing initial therapy of Leuprolide Acetate.
时间窗: 35 Weeks
次要结局
- To evaluate the safety and tolerability of the patients.(35 Weeks)
研究者
Dr Dharmesh Domadia
Cliantha Research limited
研究点 (21)
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