A randomized, open label, multi-center, two-treatment, two-period, two-sequence, two-waycross-over, multiple dose, steady state Bioequivalence (BE) study of Genus Lifesciences Inc.Nilutamide Tablets 150 mg with NILANDRON® (Nilutamide) Tablets 150 mg from ConcordiaPharmaceuticals Inc. in metastatic prostate cancer patients.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 9
- 主要终点
- To assess the steady state bioequivalence of Genus Lifesciences Inc Nilutamide Tablets 150 mg with NILANDRON
研究概览
简要总结
Metastatic prostate cancer (Stage D2) patient who are already receiving the drug at a dose of 150 mg of Nilutamide once a day as their individual therapy for at least 15 days prior to randomization meeting the above mentioned inclusion and none of exclusion criteria will be identified. Shortlisted Patients will undergo screening not before 28 days of 1st dosing. Eligible patients will be enrolled and randomized.
Upon randomization, patients will receive assigned study drug dose of Nilutamide Tablets 150 mg (T or R) based on the randomization schedule in each period. Patients will receive either Test or Reference treatment as per randomization schedule in period 01 (From day 01 to day 16) and in period 02 (From Day 17 to day 32).
Pre dose blood sample will be collected on day 14, 15, 30 and 31 prior to dosing. Study nurse/Trained personnel will explain the drug administration process on day 01 to patients.
A total of 18 blood samples will be collected during each period of study as mention in Sampling Time-points
section. Safety sample will be collected after completion/ during last PK sample of the study (i.e. on day 33).
Plasma concentrations of Nilutamide will be assayed by a validated LCMS/MS analytical method.
Statistical Analysis of pharmacokinetic parameters of test and referenceformulations will be performed to assess bioequivalence.
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
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Male
入选标准
- •The patients will be enrolled in the study based on the following inclusion criteria: a) Male Patient aged 18 to 75 years having Body Mass Index (BMI) at least 17 calculated as weight in kg/height in m2 b) Patients with biopsy confirmed prostate cancer (Stage D2) c) Patients who are already receiving 150mg of Nilutamide once a day as their individual therapy for at least 15 days prior to randomization.
- •d) Able to swallow and retain oral medication e) Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 f) Life expectancy of Greater Than 180 days.
- •g) Acceptable hematology status: Hemoglobin greater than or equal to 9 g/dL Absolute neutrophil count (ANC) greater than or equal to 1500 cells/µL Platelet count greater than or equal to 1,00,000 cells/µL h) Acceptable liver function: Alanine aminotransferase (ALT) less than or equal to 2X upper limit of normal (ULN) Aspartate aminotransferase (AST) less than or equal to 2X ULN Bilirubin less than 1.2 mg/dL Alkaline phosphatase less than or equal to 5X ULN i) Acceptable kidney function Creatinine less than or equal to 2X ULN or Creatinine clearance greater than or equal to 60 mL/minute j) Willing and able to provide written informed consent prior to any study-related activities being performed.
- •k) No history of addiction to any recreational drug or drug dependence or alcohol addiction.
排除标准
- •The patients will be excluded from the study based on the following exclusion criteria: a) Hypersensitivity to Nilutamide or to any of the excipients.
- •b) History of major respiratory, cardiac (New York Heart Association [NYHA] Type III or IV), liver, or kidney disease.
- •c) Known hypersensitivity, idiosyncratic, or allergic reactions d) In patients with severe leukopenia, neutropenia, or thrombocytopenia, e) Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganism.
- •f) Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
- •g) Surgical or other non-healing wounds.
- •h) Exposure to any investigational agent within 12 weeks prior to first dose of Investigational Product.
- •i) History of other malignancies in the last 5 years.
- •Potential patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
- •Potential patients with other malignancies that were cured with definitive primary therapy alone (e.g., surgery) and who have been continuously free of the previous disease for 1 year are also eligible upon Sponsor approval.
- •j) Severe or life-threatening infection, including known past medical history of human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS).
- •k) Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents.
- •Exceptions are alopecia (any grade is acceptable), 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], v4.03).
- •l) Uncontrolled diabetes mellitus.
- •m) Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
- •n) Any other condition(s) which could significantly interfere with Protocol compliance including, but not limited to, dementia, psychosis, cognitive impairment, altered mental status, or other major psychiatric disorder.
- •o) Donation and/or loss of 350 ml (1 unit) of blood within 90 days prior to fist dose administration of investigational product.
- •p) Positive hepatitis screening laboratory tests for hepatitis B, and/or hepatitis C.
结局指标
主要结局
To assess the steady state bioequivalence of Genus Lifesciences Inc Nilutamide Tablets 150 mg with NILANDRON
时间窗: Day 16 & Day 32
® (Nilutamide) Tablets 150
时间窗: Day 16 & Day 32
mg from Concordia Pharmaceuticals Inc. in metastatic prostate cancer
时间窗: Day 16 & Day 32
patients
时间窗: Day 16 & Day 32
次要结局
- To monitor the adverse events and to ensure the safety of Patients.(Day 16 & Day 32)