CTRI/2014/02/004394已完成未知
A Multicenter, randomized, open label, two treatment, two period, two sequence, multiple-dose, cross-over, bioequivalence study of Everolimus 10 mg tablet once daily manufactured by Par Pharmaceutical, Inc. 1 Ram Ridge Road, Spring Valley, NY 10977,USA with Afinitor (Everolimus) 10 mg tablet manufactured by: Novartis Pharma Stein AG Stein, Switzerland and Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 in Advanced Renal Cell Carcinoma patients under fasting condition
Par PharmaceuticalInc0 个研究点目标入组 48 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 48
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
- •1.Men and Women, of age in between 18 years to 65 years (both inclusive).
- •2.Ability to provide informed consent prior to participation in the study
- •3.Histologically or Cytologically confirmed diagnosis of advanced renal cell carcinoma.
- •4.Women of childbearing potential must have a negative serum pregnancy test in screening and negative urine pregnancy test on day 0 and must be using an adequate method of contraception.
- •5.Patients with advanced renal cell carcinoma and who are already receiving a stable dose of Everolimus tablets, 10 mg tablet once daily.
- •6.Adequate organ function, defined as the following:
- •Hemoglobin level >= 9 gm /dl
- •Total bilirubin < 1.5 x upper limit of normal (ULN)
- •SGOT and SGPT < 2.5 x ULN
- •Creatinine < 1.5 x ULN
- •Platelets > 100 x 10 raise to nine/L
- •Clinically non significant fasting blood glucose levels
- •7.No history of addiction to any recreational drug or drug dependence
- •8.No participation in any clinical study within the past 60 days prior to first dosing in the study.
- •9.ECOG performance status of <= 2 on the ECOG scale
- •10.Clinically acceptable ECG in opinion of the Investigator/Designee.
排除标准
- •1.A history of allergic or adverse reactions to Everolimus or any other rapamycin derivative or any of its excipients
- •2.Patients with renal failure, or for whom the need for dose change during the study can be anticipated, should be excluded.
- •3.Patient with active infection and symptoms of Non-infectious pneumonitis (symptoms such as but not limited to hypoxia, pleural effusion, cough, or dyspnea, and in whom infectious, neoplastic, and other causes have been excluded by means of appropriate investigations) as judged by the investigator.
- •4.Concurrent use of other drugs known to suppress bone marrow function
- •5.Expected changes in concomitant medications during the period of study
- •6.Positive tests for drug of abuse at baseline.
- •7.History of alcoholism / alcohol abuse.
- •8.Patients who are:
- •Breast feeding
- •Of childbearing potential without a negative pregnancy test at baseline
- •Male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial and at least 8 week after ending study treatment.
- •9.Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery
- •10.Patients with known positivity for human immunodeficiency virus (HIV), HBsAg and HCV.
- •11.Patients with any significant history of non-compliance to medical regimens
- •12.History of difficulty with donating blood or difficulty in accessibility of veins.
- •13.Patients for whom oral administration of drug is not possible.
- •14.An unusual or abnormal diet, for whatever reason e.g. religious fasting.
- •15.Patients having known brain metastasis
- •16.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study.
研究者
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