CTRI/2014/01/004325已完成不适用
A Multicentric, Open-Label, Randomized, Three-Treatment, Parallel, Single-Dose Clinical Bioequivalence Study of Subcutaneous Leuprolide Acetate 11.25 mg (Luphere Depot®)-Test 1 (T1) and Leuprolide Acetate 11.25 mg (Luphere Depot®) –Test 2 (T2) of Daewoong Pharmaceuticals Co. Ltd., in comparison with Leuprolide Acetate 11.25 mg (Lucrin Depot®) – Reference (R) of Takeda Pharmaceutical Company Ltd., in Male Prostatic Carcinoma Subjects Undergoing Initial Therapy
Daewoong Pharmaceuticals Co Ltd10 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2014年1月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 10
- 主要终点
- •Cmax
研究概览
简要总结
This study is Multicentric, Open-Label, Randomized, Three-Treatment, Parallel, Single-Dose Clinical Bioequivalence Study of Subcutaneous Leuprolide Acetate 11.25 mg (Luphere Depot®)-Test 1 (T1) and Leuprolide Acetate 11.25 mg (Luphere Depot®) –Test 2 (T2) of Daewoong pharmaceuticals Co. Ltd., in comparison with Leuprolide Acetate 11.25 mg (Lucrin Depot®) – Reference (R) of Takeda Pharmaceutical Company Ltd., in Male Prostatic Carcinoma Subjects Undergoing Initial Therapy. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The Primary objective will be to determine clinical bioequivalence of test drug (T1 & T2) with the active comparator (reference drug). The secondary objective of the study is to monitor the adverse events, to ensure safety and tolerability as assessed by reported adverse events, laboratory, clinical investigations and vital signs in the prostate carcinoma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male subjects with body mass index (BMI) between 18 and 30kg/m2 (inclusive) and aged between 45 and 75 years (both inclusive) with histologically confirmed carcinoma of prostate undergoing initial therapy with Leuprolide acetate 11.25mg 3 months depot preparation.
- •2.Testosterone levels ≥1.5ng/mL at screening.
- •3.WHO ECOG performance status between 0 and 2 (inclusive) and an expected survival of ≥ 12months .
- •4.Subjects having adequate hematologic reserve at screening as per principal investigator/sub investigator assessment.
- •5.Subjects having adequate and stable hepatic function and renal function at screening as per principal investigator/sub investigator assessment.
- •6.Subjects having normal ECG, chest X-ray (PA view) and spinal X-ray (Lateral view).
- •7.No intake of any medicinal preparations, rendering expressed influence on hemodynamic, liver functions etc (e.g., barbiturate, omeprazole, cimetidine etc.) Less than for 30 days prior to the study check-in.
- •8.No history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to study check-in.
- •9.Negative results for drugs of abuse in urine during the day of study check-in.
- •10.Negative alcohol breath analysis during the study check-in.
- •11.Subject should have given written informed consent to participate in the study.
- •12.Subjects having ability to comprehend the full nature and purpose of the study, including possible risks and adverse events; ability to co-operate with the Investigator and to comply with the requirements of the entire study.
排除标准
- •1.Evidence of severe urinary tract obstruction with anticipated urinary retention, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms.
- •2.History of chronic fatigue or worsening general health.
- •3.History of osteoporosis or bone pains.
- •4.History of tobacco ( 9 cigarettes/beedies per day) or alcohol abuse within past 3 months of screening.
- •5.History of intake of anticonvulsants and corticosteroids or any other drug known to decrease bone density.
- •6.History or evidence of thrombophlebitis, thromboembolic disorders, cerebral apoplexy.
- •7.Excruciating, severe bone pain which is due to from extensive metastatic osseous deposits (in the opinion of the Investigator), taking into account medical history, clinical observations and symptoms.
- •8.Evidence of brain metastases, taking into account medical history, clinical observations and symptoms (as decided by the investigator).
- •9.History of systemic therapy for cancer such as chemotherapy, radiotherapy or immunotherapy (e.g., antibody therapies, tumor-vaccines), biological response modifiers (e.g., cytokines) within 3 months of screening or previous local therapy to the primary tumor (external beam radiotherapy, brachytherapy, thermotherapy, cryotherapy).
- •10.History of prostatic surgery (e.g., radical prostatectomy, transurethral resection of the prostate [TUR-P]) or orchiectomy, adrenalectomy or hypophysectomy.
- •11.Intake of any investigational drugs within 5 half-lives of its physiological action or 3 months (whichever is longer) before screening.
- •12.Previous treatment with AR-receptor blockers, such as Casodex®, Fugerel®, Megace®, Androcur® (no wash-out allowed) or 5-α-reductase inhibitors (Proscar®, Avodart®, Propecia®) or Over-the-counter (OTC) or alternative medical therapies which have an estrogenic or anti-androgenic effect (i.e., PC-SPES, saw palmetto, Glycyrrhiza®, Urinozinc®, DHEA) within the 3 months before screening .
- •13.Administration of hormonal therapy, including GnRH analogs (except Leuprolide acetate 11.25 mg 3 months depot preparation) (less than or equal to 6 month depot administration), estrogen, megace and phytotherapy, within 32 weeks prior to the screening visit and during the study.
- •14.History of uncontrolled diabetes mellitus.
- •15.History of blood donations/losses within 3 months of screening.
- •17.History of any coagulation or bleeding abnormality 18.History of venous thrombosis within 6 months prior to baseline.
- •19.Significant Pre-existing co-morbidities a.Cardiovascular •Myocardial infarction within the last 6 months •Congestive heart failure •Unstable angina •Active cardiomyopathy •Cardiac arrhythmia •Uncontrolled hypertension •History of familial long QT syndrome or sudden cardiac death b.Pulmonary •Pulmonary disease requiring oxygen c.Neurologic and psychiatric •History of significant neurologic or psychiatric disorder that would preclude study compliance or ability to give informed consent.
- •Gastrointestinal (GI) •GI conditions that would preclude compliance with oral medication e.Other cancer(s) •Other malignancy than carcinoma of prostate within the past 5 years.
- •20.Subjects positive for HIV 1 & 2/HBsAg/HCV at screening.
- •Any deviation from a normal diet e.g. religious fasting.
- •22.Consumption of grape fruit juice within the 48 hours prior to study check-in.
- •24.History of any disorder that interferes with the blood sampling during the study.
结局指标
主要结局
•Cmax
时间窗: •Day1,3,7,14,21,28,35 and Day 42
•AUC 0- 42 Day
时间窗: •Day1,3,7,14,21,28,35 and Day 42
次要结局
- •Tmax: Time of the maximum measured serum concentration.(•Safety and tolerability)
研究者
研究点 (10)
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