CTRI/2020/12/029491进行中（未招募）1 期
A randomized, multi-center, open-label, two-treatment, two-sequence, two-period, crossover, steady state bioequivalence study of Sunitinib Malate 50 mg hard capsules manufactured byReliance Life Sciences Pvt. Ltd., India with reference SUTENT�® (Sunitinib Malate 50 mg hard(capsules) distributed by Pfizer Labs, Division of Pfizer Inc., NY in adult cancer patients under treatment with stable dose of Sunitinib malate capsules under non-fasting (fed) condition
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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. Adult patients suffering from advanced renal cell carcinoma or gastrointestinal stromal
- •2. Patients with confirmed diagnosis of advanced renal cell carcinoma or gastrointestinal stromal tumour already receiving a stable once-daily dose of Sunitinib 50 mg for at least 2 weeks.
- •3.Patient has adequate organ function, defined as following:
- •- Hemoglobin ââ?°Â¥9.0 g/dL
- •- Absolute neutrophil count (ANC) ââ?°Â¥ 1500 cells/mm3
- •- Platelet count ââ?°Â¥ 100,000/ mm3
- •- Total bilirubin ââ?°Â¤1.5 x Upper Limit of Normal (ULN)
- •- Serum SGPT / SGOT ââ?°Â¤ 2.5 x ULN
- •- Serum albumin ââ?°Â¥2 g/dL
- •- Serum Creatinine < 1.5 x ULN
- •4. Patients willing to voluntarily provide written informed consent.
- •5.Males with female partners of reproductive potential must be willing to use a male condom
- •during sexual intercourse during the study period and for ten weeks after the last dose of study medication.
- •6.Patients willing to undergo pre and post-study physical examinations and laboratory
- •investigations.
- •7. Eastern Cooperative Oncology Group performance status of <2.
- •8.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 and during their clinical stay in each study period.
- •9.Patient should be willing to adhere to the protocol and they should not consume alcohol at
- •least 48 hours prior to dosing and should agree not to take any amount of alcohol during the
- •study period.
- •10. Patients able and willing to comply with the protocol requirements.
排除标准
- •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 clinically significant organ dysfunction or any clinically
- •significant deviation from normal in their physical or clinical evaluation including ECG, 2D, Echocardiography and X-ray results.
- •5. Any treatment which could affect the pharmacokinetic of Sunitinib /known
- •interactions
- •6. Patients with a known history of drug hypersensitivity to Sunitinib or any excipients of the formulation.
- •7. History of difficulty in swallowing, or any gastrointestinal disease e.g. ulcerative colitis, ulcerative stomatitis, malabsorption syndrome and/or lack of physical integrity of the upper intestinal tract which could affect drug absorption
- •8. 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).
- •9. Patients who are diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV)
- •virus reactive/positive.
- •10.Patients with clinically significant abnormal haemoglobin (Hb), total white blood cells count (WBC), differential WBC count, platelet count and hematocrit
- •11. 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), serum bilirubin, serum glucose (fasting) , thyroid function tests and serum electrolytes.
- •12. Patients with a clinically significant past history or current medical condition of:
- •Ã¯â??· Pulmonary disorders (COPD and asthma)
- •Cardiovascular disorders QTc interval >450 msec for males or >470 msec for
- •females, uncontrolled hypertension), abnormal 2 D ECHO with LVEF <45%
- •Ã¯â??· Neurological disorders (especially seizures, migraine)
- •Ã¯â??· Hepatic disorders
- •Ã¯â??· Abnormal thyroid function
- •Ã¯â??· Grade ââ?°Â¥3 hemorrhage within 4 weeks prior to first IP dosing
- •Ã¯â??· Thrombotic micro-angiopathy (TMA), including thrombotic thrombocytopenic
- •purpura and hemolytic uremic syndrome
- •13. Females of childbearing and reproductive potential not willing to follow following
- •requirement.
- •Ã¯â??· Females of childbearing potential ready to undergo serum pregnancy test at screening
- •and urine pregnancy test at subsequent visit as per protocol requirement and
- •investigators assessment
- •Ã¯â??· Females of childbearing and reproductive potential must be willing to use adequate
- •contraception (as defined below) at least four weeks before the first dose of the study
- •drug except as noted and continuing at least four weeks after the last dose of the study
- •drug. For this study, acceptable and effective methods of contraception for females
- •Ã¯Æ?Ë?Intrauterine device placed at
研究者
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