CTRI/2014/08/004909尚未招募不适用
A two stage, randomized, multicentric, open-label, multiple dose, two-treatment, two-sequence, two-period, crossover, steady state bioequivalence study of test Nilutamide 150 Mg tablets (from EirGen Pharma Ltd.,Ireland) with reference Nilandron 150 mg tablets of Sanofi-aventis U.S. LLC in prostate cancer patients under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- Bioequivalence of the two formulations (T vs R) in relation to the:
研究概览
简要总结
The study is designed as two stage, randomized, multicentric, open-label, multiple dose, two-treatment, two-sequence, two-period, crossover, steady state bioequivalence study of test Nilutamide 150 Mg tablets (from EirGen Pharma
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria 1.Adult patients suffering from prostate cancer; aged between 18 to 70 years.
- •2.Patients with histologically confirmed prostate cancer not amenable to curative therapy with surgery or radiation, and had evidence of progressive disease despite treatment with adequate hormonal therapy, as defined by continued treatment with an LHRH agonist or previous orchidectomy, and after treatment with either/or both flutamide or bicalutamide 3.Patients willing to voluntarily provide written informed consent.
- •4.Patients willing to undergo pre and post-study physical examinations and laboratory investigations.
- •5.Eastern Cooperative Oncology Group performance status of 0–2 6.Patients willing to adhere to protocol and they should not consume coffee, tea, chocolate, grape fruit juice or soft drink at least 24 hours prior to investigational product administration (i.e. in-house monitoring and the remaining based on history) and during their clinical stay in each study period.
- •7.Patient should be willing to adhere to the protocol and they should not consume alcohol at least 48 hours prior to dosing (i.e. in-house monitoring and the remaining based on history) and should agree not to take any amount of alcohol during the study period.
- •8.Patients able and willing to comply with the protocol requirements.
排除标准
- •Exclusion Criteria 1.Patients incapable of understanding the informed consent process.
- •2.Patients with inadequate venous access in their left or right arm to allow the collection of all samples via venous cannula in the study 3.Patients with evidence of psychiatric disorder likely to limit the validity of consent to participate in the study, or limit the ability to comply with the protocol requirements.
- •4.Patients with any evidence of organ dysfunction or any clinically significant deviation from normal in their physical or clinical evaluation including ECG and X-ray results.
- •5.Any treatment which could affect the pharmacokinetic of Nilutamide/known interactions 6.Patients with a known history of drug hypersensitivity to nilutamide or any excipients of the formulation.
- •7.Patients with a history of alcohol, found with current alcohol abuse based on Alcohol breath test and with history of drug abuse, found urinary screen test positive for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates).
- •8.Patients who are diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus reactive/positive.
- •9.Patients with clinically significant abnormal haemoglobin (Hb), total white blood cells count (WBC), differential WBC count, platelet count and hematocrit 10.Patients who, have clinically significant abnormal laboratory values for serum creatinine, blood urea nitrogen, (BUN), serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase (ALP), c-glutamyltranspeptidase, serum bilirubin, serum glucose (fasting) etc.
- •11.Patients with clinically significant abnormal urine analysis, defined as the presence of RBC (5/HPF), pus cells (5/HPF), epithelial cells (5/HPF), glucose (positive), ketones (positive), bilirubin (positive) and protein (positive).
- •12.Patients with a clinically significant past history or current medical condition of: •Pulmonary disorders (COPD and asthma) •Cardiovascular disorders (especially cardiac blocks) •Neurological disorders (especially seizures, migraine) •Renal and/or hepatic disorders •Visual abnormality 13.Patients who have participated in any other clinical investigation or have bled more than 300 ml in the past 3 months.
结局指标
主要结局
Bioequivalence of the two formulations (T vs R) in relation to the:
时间窗: Bioequivalence of the two formulations (T vs R) in relation to the: | Rate of absorption | Extent of absorption
Rate of absorption
时间窗: Bioequivalence of the two formulations (T vs R) in relation to the: | Rate of absorption | Extent of absorption
Extent of absorption
时间窗: Bioequivalence of the two formulations (T vs R) in relation to the: | Rate of absorption | Extent of absorption
次要结局
- To monitor all the adverse events, including laboratory parameters
研究者
研究点 (8)
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