CTRI/2025/09/094579招募中不适用
An Open Label, Multi-Center, Randomized, Single-Dose, Balanced, Two-Treatment, Parallel, Pharmacokinetic Bioequivalence Study of Leuprolide Acetate for Depot Suspension (30 mg For 4-Month, 16 Weeks) of American Regent, Inc. with Lupron Depot (Leuprolide Acetate for Depot Suspension 30 mg For 4-Month, 16 Weeks) of Abbvie Inc. North Chicago, IL 60064 in Adult Male Prostatic Carcinoma Participants Undergoing Initial Therapy or Receiving a Stable Regimen of Leuprolide Acetate.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 850
- 试验地点
- 32
- 主要终点
- To establish bioequivalence between American Regent, Inc.s test formulation of Leuprolide acetate for depot suspension (30 mg for 4-month, 16 weeks) and the reference listed drug (RLD), Lupron Depot (leuprolide acetate for depot suspension; 30 mg for 4-month, 16 weeks) of AbbVie Inc. North Chicago, IL 60064 in adult male prostatic carcinoma participants undergoing initial therapy or receiving a stable regimen of leuprolide acetate administered via intramuscular injection route .
研究概览
简要总结
An Open Label, Multi-Center, Randomized, Single-Dose, Balanced, Two-Treatment, Parallel, Pharmacokinetic Bioequivalence Study of Leuprolide Acetate for Depot Suspension (30 mg For 4-Month, 16 Weeks) of American Regent, Inc. with Lupron Depot (Leuprolide Acetate for Depot Suspension; 30 mg For 4-Month, 16 Weeks) of Abbvie Inc. North Chicago, IL 60064 in Adult Male Prostatic Carcinoma Participants Undergoing Initial Therapy or Receiving a Stable Regimen of Leuprolide Acetate.
Objective:
1. To establish pharmacokinetics between American Regent, Inc.s test formulation of Leuprolide acetate for depot suspension (30 mg for 4-month, 16 weeks) and the reference listed drug (RLD), Lupron Depot (leuprolide acetate for depot suspension 30 mg for 4-month, 16 weeks) of AbbVie Inc. North Chicago, IL 60064 in adult male prostatic carcinoma participants undergoing initial therapy or receiving a stable regimen of leuprolide acetate administered via intramuscular injection route. To assess the safety of study products.
2. Qualitative comparison of the pharmacodynamics markers (testosterone, PSA, LH and FSH) after the single dose administration of the two formulations of leuprolide acetate for depot suspension (30 mg for 4-month, 16-weeks) administered via intramuscular injection route (Test and RLD) in the study participant population.
3. To monitor the general safety and tolerability of the leuprolide acetate for depot suspension injections administered via intramuscular injection route in the study participant populations.
研究设计
- 研究类型
- Ba/be
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •Willing and able to provide voluntary informed consent prior to commencement of any study-related activities, and the ability to follow protocol requirements
- •Male participants aged 18 years and older and having body mass index (BMI) between 18.00 to 30.00 kg/m2 (both inclusive) at the screening visit
- •Male participants with histologically/cytologically confirmed carcinoma of the prostate
- •Participants in the PI judgement who are eligible or require leuprolide acetate long-acting depot injection (30 mg, 4-months)
- •Participants who, a.
- •newly diagnosed with locally advanced and/or metastatic prostate cancer (diagnosed within 6 months prior to screening and have not received any prior anticancer treatment) and scheduled to receive their first dose of leuprolide acetate as a part of their standard of care OR b.
- •already receiving a stable regimen of leuprolide acetate via intramuscular injection route and in the PI judgement are eligible for switching to longer duration dosage form such as 30 mg for every 4 months (16 weeks).
- •Participants with histologically/cytologically confirmed advanced carcinoma of prostate (Stage T(1b-4), N(any), M(any)) who would benefit from GnRH agonist Note: Participants with previous history of radical prostatectomy, trans urethral resection of the prostate (TUR-P) can be included.
- •Participants should have complete recovery from surgery before screening
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equals to.
- •Acceptable hematology status a.
- •Hemoglobin greater than or equals to 9 g/dL b.
- •Absolute neutrophil count (ANC) greater than or equals to 1500 cells/mm3 c.
- •Platelet count greater than or equals to 100,000 cells/mm3
- •Acceptable liver function: a.
- •Alanine aminotransferase (ALT) less than or equals to 2 x ULN (less than or equals to 5 x ULN if liver metastases present) b.
- •Bilirubin less than or equals to 1.5 x ULN d.
- •Alkaline phosphatase less than or equals to 2 x ULN and less than or equals to 5 x ULN if bone metastasis is present
- •Participants with adequate renal function at screening as defined by serum creatinine less than 1.5 times ULN (Upper Limit of Normal) for the clinical laboratory
- •Participants with HbA1c less than or equals to 8 percent
- •Participants with life expectancy of at least 6 (six) months at the time of enrolment
- •Participants who wish to bank their semen must agree to semen banking prior to 24 hours of receiving the first dose of Investigational Product
- •Participants who agree to use adequate male contraceptive methods while in the study.
排除标准
- •Known hypersensitivity or contraindication to gonadotropin-releasing hormone (GnRH), GnRH agonist or to any of the components of investigational product
- •History of prior prostatic surgery (e.g. orchidectomy, hypophysectomy or adrenalectomy and hypophysectomy)
- •History of radiotherapy, chemotherapy, immunotherapy, radiation therapy, cryotherapy, strontium, or biological response modifiers as prostate therapy within 8 weeks prior the screening visit
- •Participants that received hormonal manipulation within 32 weeks prior to the screening visit (i.e. GnRH analogues except Leuprolide acetate formulations, estrogen, megace and phytotherapy)
- •Received therapy with a GnRH analogue (1 year implant) within 60 weeks prior to the screening visit
- •Indication of clinically significant urinary tract obstruction or spinal cord compression
- •History of any major surgical procedure (including periodontal) within 28 days prior to receiving an investigational product
- •Corrected QT interval [Fridericia formula (QTc)] greater than 450 msec at screening visit or before dosing
- •Concurrent medications that may prolong the QT/QTc interval
- •Presence of any uncontrolled systemic disease (e.g. cardiovascular disease Myocardial infarction within 6 months, Unstable angina, Congestive cardiac failure, Cardiac arrhythmia, History of familial long QT syndrome, hypertension, diabetes mellitus etc.)
- •Known history of CNS metastasis and other malignancies in the last 5 years (except in situ cancer of cervix or basal or squamous cell skin cancer).
- •Surgical or other non-healing wounds
- •Participants with positive serology for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV)
- •Participant with history or presence of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumours or participants who are on concomitant medications that have been associated with convulsions such as bupropion and Selective serotonin reuptake inhibitors (SSRIs)
- •Participants with positive urine screen for alcohol test or drugs of abuse
- •Smokers who smoke greater than or equals to 10 cigarettes or equivalents per week
- •Participants with history of Severe Cutaneous Adverse Reactions (SCARs) including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN)
- •Have not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational products used to treat cancer other than locally advanced and/or metastatic prostate cancer.
- •Exceptions are alopecia (any grade is acceptable), hemoglobin greater than or equals to 9 g/dL, fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V 5.0)
- •Participation in any clinical study within 90 days prior to receiving the investigational product (IP) of the current study, excluding leuprolide acetate long-acting injectable products
- •Any other medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the participant to participate in the study, including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements
- •History of hypogonadism
- •Received therapy with finasteride or ketoconazole within 1 week prior to the screening visit; dutasteride within 25 weeks prior to the screening visit
- •Participants who had major surgery (other than those specified in criteria 2) within 4 weeks prior to the screening visit, or who have not recovered from prior major surgery
- •Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study (except 30 days for the treatments with leuprolide acetate products)
- •History of addiction to any recreational drug or drug dependence or alcohol addiction within 12 months before the screening visit
- •Any condition/ abnormal baseline findings that in the investigators judgment might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to obtain objective of the study e.g. low expectation of compliance to dosing or expected changes in concomitant medication that may interfere in study.
结局指标
主要结局
To establish bioequivalence between American Regent, Inc.s test formulation of Leuprolide acetate for depot suspension (30 mg for 4-month, 16 weeks) and the reference listed drug (RLD), Lupron Depot (leuprolide acetate for depot suspension; 30 mg for 4-month, 16 weeks) of AbbVie Inc. North Chicago, IL 60064 in adult male prostatic carcinoma participants undergoing initial therapy or receiving a stable regimen of leuprolide acetate administered via intramuscular injection route .
时间窗: 16 Weeks
次要结局
- To assess the general safety & overall well-being of the study participants(16 weeks)
研究者
Dr Dharmesh Domadia
Cliantha Research Limited
研究点 (32)
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