CTRI/2015/12/006440尚未招募不适用
A RANDOMIZED, OPEN LABEL, TWO TREATMENT, MULTIPLE DOSE, CROSSOVER, PIVOTAL, STEADY STATE BIOEQUIVALENCE STUDY OF NILUTAMIDE TABLET, 150 MG MANUFACTURED BY STASON PHARMACEUTICALS, INC. USA WITH NILANDRON (NILUTAMIDE) TABLET, 150 MG OF COVIS PHARMA SARL. USA (acquired by CONCORDIA, USA) IN METASTATIC PROSTATE CANCER PATIENTS UNDER FED CONDITION.
Stason Pharmaceutical Inc5 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- To demonstrate pharmacokinetic bioequivalence of Nilutamide tablet 150 mg manufactured by Stason Pharmaceuticals, Inc., versus Nilandron (Nilutamide) tablet, 150 mg of Covis Pharma Sarl (acquired by CONCORDIA, USA) in Metastatic Prostate Cancer Patients.
研究概览
简要总结
The current study will be a randomized, open label, Two Treatment, multiple dose, crossover, pivotal, steady state bioequivalence study of Nilutamide tablet, 150 mg of Stason Pharmaceuticals, Inc. in metastatic prostate cancer patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Patients willing to participate by providing written informed consent. 2.Male between 30 to 70 years of age with a histopathologically confirmed metastatic prostate cancer consistent with stage D2 (Stage IV [subtype D2] metastatic prostate cancer). 3.Body mass index of 18–25 kg/m2 (both inclusive). 4.Patients who completed the active run-in period (30 days at 300mg followed by 150 mg once a day as their individual therapy for at least 15 days prior to randomization). 5.Performance status with 0 or 1 as per Eastern Cooperative Oncology Group (ECOG) scale. 6.Life expectancy must be ≥ 6 months. 7.Laboratory values must be as follows: White blood cell count: ≥ 3,000/mm3, Absolute granulocyte count: ≥ 1,500/mm3 Platelets: ≥ 100,000/mm3 Hemoglobin: ≥ 8g/dL Serum creatinine:≤ 1.5 x upper limit of normal (ULN) Alkaline Phosphatase ≤3 x UNL AST: ≤ 3 x ULN ALT: ≤3 x ULN Serum calcium: ≤ ULN Total bilirubin: ≤1.5 x ULN 8.Patient must be willing to provide written informed consent and agree to.
- •use effective contraception while on treatment and for three months after completion of therapy.
排除标准
- •1.Patients with any pre-planned inpatient hospitalizations for a procedure or elective surgery that would occur during participation in the study.
- •2.Patients with a history of severe hypersensitivity reaction to nilutamide or any component of this preparation.
- •3.Patient has received any other investigational agent within 90 days of first day of study drug dosing.
- •4.Patient has another severe and/or life-threatening medical disease.
- •5.Patients with evidence of recent deep venous thrombosis, pulmonary emboli, unstable angina or clinical congestive heart failure.
- •6.Patients with a prior history of myocardial infarction, pulmonary embolism, cerebral vascular accident (CVA) or atrial fibrillation.
- •7.Patients with evidence of active angina as evidenced by chest pain responsive to sublingual nitroglycerin or other anginal equivalent.
- •8.Patients with known evidence of brain metastases or carcinomatous meningitis.
- •9.Patients with a history of other cancers except curatively-treated non-melanomatous skin cancer.
- •Other cured tumors may be entered after discussion with and approval of the study chair.
- •10.Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
- •12.Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
- •13.Patients with current peripheral neuropathy of any etiology that is greater than Grade I.
- •15.Prior radiation therapy is allowed; at least 21 days must have elapsed since completion of radiation therapy, and patients must have recovered from side effects.
- •16.Patients may have received prior surgery; at least 21 days must have elapsed since completion of surgery and patient must have recovered from all side effects.
- •17.Previous history or evidence of drug abuse in past 10 years 18.Positive serological tests for HIV, Hepatitis B &/or C.
- •19.Patient who are considered for any reason by the investigator to be inappropriate for study participation.
- •20.Patient who are not expected to survive for the duration of the study.
- •21.Refuse to abstain from food for at least 10 h before dosing and for at least 4 h after dose in each period.
- •22.Refuse to abstain from fluid for at least 1 h before and 1 h after dosing.
- •23.Patients with documented anti androgen withdrawal syndrome with nilutamide.
结局指标
主要结局
To demonstrate pharmacokinetic bioequivalence of Nilutamide tablet 150 mg manufactured by Stason Pharmaceuticals, Inc., versus Nilandron (Nilutamide) tablet, 150 mg of Covis Pharma Sarl (acquired by CONCORDIA, USA) in Metastatic Prostate Cancer Patients.
时间窗: Two 28 days assessment periods i.e. on 56th day assessment will be done. tablet 150 mg manufactured by Stason Pharmaceuticals, Inc., versus Nilandron (Nilutamide) tablet, 150 mg of Covis Pharma Sarl (acquired by CONCORDIA, USA) in Metastatic Prostate Cancer Patients.
次要结局
- To assess the safety and tolerability of Nilutamide tablets(During the study period)
研究者
研究点 (5)
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