CTRI/2011/12/002274招募中未知
A multicentre, randomized, open-label, single dose, two treatment, two period, two sequence, crossover, pivotal bioequivalence study of Test Temozolomide 250 mg capsule manufactured by Reliance Life Sciences Pvt. Ltd., India with Reference Temodal 250 mg capsule of Schering- Plough Ltd, UK in adult, male and/or female cancer patients under fasting conditions. - NA
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •Male or female 18 to 70 years of age.
- •Patients with Body Mass Index (BMI) between 17 kg/m2 and 30 kg/m2.
- •Cancer patients (glioblastoma multiforme or anaplastic astrocytoma) who are already receiving or are about to start receiving temozolomide 250 mg once daily as their calculated individualized dose (e.g. based upon factors such as tumor type, body surface area, cycle number and toxicity).
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status <=2.
- •Patients with Karnofsky Performance Status of at least 70%.
- •Patients with life expectancy of atleast 3 months.
- •Patients should be non-smokers.
- •Patients willing to voluntarily provide written informed consent or consent from Legally
- •Acceptable Representative (LAR), if subject is not in the condition to give consent.
排除标准
- •Patients with inadequate venous access to allow the collection of all samples via venous cannula in the study.
- •Pregnant (female subjects with a positive serum pregnancy test at screening and positive urine pregnancy test before check-in in period I) or lactating females.
- •Patients with abnormal laboratory parameters like:
- •a. Serum creatinine greater than 2.0 times of upper normal limit
- •b. AST or ALT greater than 2.5 times of upper normal limit
- •c. Alkaline phosphatase >=1.5 times of upper normal limit
- •d. Platelet count less than 100,000/μL.
- •e. Hemoglobin less than 8.0 g/dL.
- •f. Total WBC Count less than 4000 /µL
- •g. ANC value less than 1500 /µL
- •Seizure symptoms, which significantly interfere with normal life and restrict medical treatments that are necessary for patient care.
- •Patients with chemotherapy or biologic anticancer therapy within 4 weeks before study or nitrosourea therapy within 6 weeks before study entry.
- •Patients planned or currently receiving focal radiotherapy.
- •Patients with a known history of drug hypersensitivity to temozolomide or any of the excipients of the formulations.
- •Patients with known hypersensitivity to dacarbazine (DTIC).
- •Patients with known history of galactose intolerance or glucose-galactose malabsorption.
- •History or evidence of cardiac disease (Myocardial Infarction in last 6 months, unstable angina, heart failure, uncontrolled ventricular arrhythmia, significant pericardial disease).
- •Patients with a history of alcohol, found with current alcohol abuse based on Alcohol breath test and/ or drug abuse or who are found urinary screen test positive for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates) except required as medication for current medical condition.
- •Patients diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
- •Patients receiving sodium valproate
- •Patients who participated in any other clinical investigation using experimental drugs or have bled more than 300 mL in the past 3 months.
- •History or evidence of clinically significant systemic disease or any other condition which investigator feels would pose a significant hazard to patients if IP is administered.
研究者
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