CTRI/2011/11/002104招募中不适用
A randomized, multiple site, open label, two treatment, two period, two sequence, multiple-dose, crossover, bioequivalence study of Etoposide 50mg Capsules of Banner Pharmacaps, USA compared with Etoposide 50mg Capsules of Mylan Inc., USA in adult patients with small cell lung cancer under fasting steady-state conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 8
- 主要终点
- To compare and evaluate the rate and extent of absorption of Etoposide 50mg Capsules of Banner Pharmacaps, USA compared with Etoposide 50mg Capsules of Mylan Inc., USA in adult patients with small cell lung cancer under fasting steady-state conditions.
研究概览
简要总结
Primary Objective : To compare and evaluate the rate and extent of absorption ofEtoposide 50mg Capsules of Banner Pharmacaps, USA compared with Etoposide 50mg Capsules of Mylan Inc., USA in adult patients with small cell lung cancer under fasting steady-state conditions.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients aged 18years of age or older.
- •Patients already receiving etoposide and expected to receive at least two additional cycles at the same dose.
- •Eastern Cooperative Oncology Group (ECOG) performance status <
- •Life expectancy > 3 months.
排除标准
- •The patients will be excluded from study, if they meet any of the following criteria: Hypersensitivity to Etoposide or related class of drugs.
- •Extensive disease treatable with radiotherapy.
- •Past or current history of other malignant disease.
- •Concurrent severe medical problems other than small cell lung cancer.
- •Patients with central nervous system metastases receiving more than 12 mg /day dexamethasone or equivalent to control symptoms.
- •Patient had a clinically significant history of cardiac disease; Patient had pre-existing severe motor or sensory neuropathy higher than grade 1, according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (34); had active infections or other serious concomitant medical conditions that would impair the ability of a patient to receive the protocol treatment; Patients with low serum albumin.
- •Patient had dementia.
- •Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period for a least 1 month before and at least 3 months after the completion of the study.
- •Women who are pregnant or breastfeeding.
- •Men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above.
- •Known CYP450 strong inhibitors2 such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir or telithromycin and well known inducers2 such as rifampin, carbamazepine, rifabutin, rifapentin, dexamethasone, phenytoin, phenobarbital, and St. Johns wort within 1 month of the study starting.
- •History or presence of significant alcoholism or drug abuse in the past one year.
- •History or presence of asthma, urticaria or other significant allergic reactions.
- •History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- •Difficulty with donating blood.
- •Difficulty in swallowing solids like tablets or capsules.
- •Patients with any other condition which in the Investigators opinion would not make the patient a good candidate for the clinical trial.
- •Severe medical problems other than the cancer that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk.
- •Participation in a drug research study within past 3 months.
- •Donation of blood in the past 3 months before screening.
- •Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- •History or presence of significant easy bruising or bleeding.
- •History or presence of significant recent trauma.
结局指标
主要结局
To compare and evaluate the rate and extent of absorption of Etoposide 50mg Capsules of Banner Pharmacaps, USA compared with Etoposide 50mg Capsules of Mylan Inc., USA in adult patients with small cell lung cancer under fasting steady-state conditions.
时间窗: The pre-dose blood sample of 3.5mL (0.00 hr) will be collected within 5 minutes prior to dosing time on Day 3, 4 and 5. On Day 5 the post-dose blood samples of 3.5mL each will be drawn at 15, 20, 30, 45 and 60 mins and then 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, and 48.00 hrs following drug administration in each period.
次要结局
- •To monitor the adverse events of Etoposide and to ensure the safety of patients.(N/A)
研究者
研究点 (8)
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