CTRI/2020/10/028442已完成不适用
An open label, multicenter, balanced, randomized, parallel, two-treatment, single-period,single dose bioequivalence study of Leuprolide acetate 30 mg of Pharmathen S.A.,Greece with LUPRON DEPOT (leuprolide acetate for depot suspension) 30 mg ofAbbVie Inc. North Chicago, IL 60064 in adult male subjects with advanced prostaticcancer undergoing initial therapy under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 10
- 主要终点
- To assess the bioequivalence between Leuprolide acetate 30 mg of Pharmathen S.A., Greece and LUPRON DEPOT (leuprolide acetate for depot suspension) 30 mg of AbbVie Inc. North Chicago, IL 60064 in adult male subjects with advanced prostatic cancer undergoing initial therapy under fasting conditions.
研究概览
简要总结
Patients requiring dose of Leuprolide acetate depot 30 mg intramuscular injection once every 16 weeks will be enrolled in the parallel design study. If the patient is found suitable for the study enrollment based on the eligiblity assessment , patient will be randomized to receive single dose of leuprolide acetate depot 30 mg intramuscular injection (either the test or reference product) on day 1 as per the randomization schedule.
Total 36 PK samples will be collected per patient in the study.
All PK samples after 24 hrs will be ambulatory.
Serum concentration of leuprolide will be quantified using validated analytical methods.
Statistical analysis of PK parameters of test and or reference formulations will be performed using SAS version 9.04 or higher to assess bioequivqlence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male patients having a BMI of 18.5-30 kg/m2 (both inclusive).
- •Ability to understand and provide written informed consent prior to participation in the study and willing to comply with the study requirements as per protocol.
- •Patients who require Leuprolide Acetate Depot Injection, 30mg, every 16 weeks.
- •Patients with histologically/cytologically confirmed advanced carcinoma of prostate (Stage T(1b-4), N(any) , M(any)) who would be benefit from GnRH agonist.
- •Newly diagnosed advanced prostatic cancer patients that are scheduled to receive their first dose of leuprolide acetate as a part of their standard of care.
- •Testosterone levels ≥1.5ng/mL at screening.
- •Patients with an ECOG Performance Status Score < 2
- •Patients with hemoglobin ≥ 9.0 g/dL.
- •No history of addiction to any recreational drug or drug dependence or alcohol addiction.
- •Patients with HbA1c ≤ 7 % at screening
- •Patients with life expectancy of at least 6 months at the time of enrolment as judged by Investigator.
- •Patients/ partner agreeing to use adequate contraceptive methods during the study.
排除标准
- •1.Known hypersensitivity or contraindication to GnRH, GnRH agonist or to any of the components of investigational product.
- •2.History of prostatic surgery (e.g., radical prostatectomy, transurethral resection of the prostate [TUR-P]), orchiectomy, adrenalectomy and hypophysectomy.
- •3.History of radiotherapy, chemotherapy, immunotherapy, radiation therapy, cryotherapy, strontium, or biological response modifiers as prostate therapy within 8 weeks prior the screening visit.
- •4.Patients that received hormonal manipulation within 32 weeks prior the screening visit (i.e. GnRH analogues, estrogen, megace and phytotherapy) 5.Patients requiring additional treatment (i.e. radiotherapy) 6.History of hypogonadism 7.Received therapy with finasteride or ketoconazole within 1 week prior to the Screening Visit; dutasteride within 25 weeks prior to the Screening Visit.
- •8.Received therapy with a GnRH analog (1 year implant) within 60 weeks prior to the Screening Visit.
- •9.Positive tests for drug or alcohol abuse at screening or baseline.
- •10.Patient had major surgery (other than those specified in criteria 2) within 4 weeks prior to study entry, or who have not recovered from prior major surgery.
- •11.Patients with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV.
- •12.Is either a non-smoker or ex-smoker who has not used any nicotine containing products in the last 6 months before day 1 of study treatment.
- •13.History of difficulty with donating blood or difficulty in accessibility of veins.
- •15.Clinical indication of urinary tract obstruction.
- •16.History or presence of any uncontrolled debilitating systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.) 17.Significant pre-existing cardiovascular co morbidities i.e. • Myocardial infarction within 6 month • Unstable angina • Congestive cardiac failure • Cardiac arrhythmia • History of familial long QT syndrome 18.Known CNS metastasis.
- •19.Patients having history of convulsion, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. 20.Concurrent medications that may prolong the QT/QTc interval.
- •21.A marked baseline prolongation of QTc interval (QTc interval >450 milliseconds (ms)) 22.History of other malignancies in the last 5 years (except in situ cancer of cervix or basal or squamous cell skin cancer).
- •23.Participation in any clinical study within 90 days prior to receiving the first dose of Investigational Product.
- •24.Any condition/ abnormal baseline findings that in the investigator’s judgment might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the 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 assess the bioequivalence between Leuprolide acetate 30 mg of Pharmathen S.A., Greece and LUPRON DEPOT (leuprolide acetate for depot suspension) 30 mg of AbbVie Inc. North Chicago, IL 60064 in adult male subjects with advanced prostatic cancer undergoing initial therapy under fasting conditions.
时间窗: A total of 36 pharmacokinetic blood samples will be collected per patient the during study. All PK samples after 24.00hrs. will be ambulatory. Visit 3-21: Ambulatory PK sample collection visit (on days 3, 4, 7, 11, 15, 19, 23, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 105) Visit 22: End of study visit: Ambulatory PK sample collection visit (on day 112) and safety assessment.
次要结局
- To monitor the adverse events and to ensure the safety of(patients exposed Investigational Medicinal Product.)
研究者
研究点 (10)
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