CTRI/2017/09/009930已完成未知
A randomized, open-label, single dose, two treatment,three-period, three-sequence, partialreplicate, crossover, multicenter, bioequivalencestudy of Capecitabine 500 mg tablets(manufactured by Reliance Life Sciences Pvt.Ltd., India) with Xeloda® (Capecitabine 500 mgtablets distributed by Genentech USA, Inc.) inadult cancer patients under fed condition.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 84
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. Males or non-pregnant or non-lactating females of age between 18 to 65 years (both inclusive).
- •a) Females of childbearing potential must have a negative serum pregnancy test at screening
- •and negative urine pregnancy test at period I hospitalization. Females of childbearing
- •potential include females who have entered puberty and all women who have a uterus and
- •ovaries and have not completed menopause. Females who have 12 consecutive months of
- •spontaneous amenorrhea (not amenorrhea induced by a medical condition or medical
- •therapy) or have bilateral absence of the ovaries (surgical or congenital) have completed
- •b) Females of 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 six months after the last dose of the study drug. For this study,
- •acceptable and effective methods of contraception for females includei.
- •Intrauterine device placed at least 3 months prior to the start of the study and
- •remaining in place during the study period,
- •ii. Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge,
- •or vaginal spermicide plus a male or female condom) or
- •iii. Absolute sexual abstinence (no sexual intercourse or genital contact with a male
- •c) Females will not be considered of childbearing potential if one of the following is reported
- •and documented on the medical history:
- •i. Postmenopausal with spontaneous amenorrhea for at least one year; or
- •ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding
- •for at least 6 months; or
- •iii. Total hysterectomy and an absence of bleeding for at least 3 months
- •d) Males with female partners of reproductive potential must be willing to use a male condom
- •throughout the entire study and continuing for three months after the last dose of study
- •medication.
- •2. Patients in whom capecitabine therapy is indicated
- •i. Dukesâ?? C colon cancer: Adjuvant therapy; or
- •ii. Metastatic colorectal cancer: First-line as monotherapy when treatment with
- •fluoropyrimidine therapy alone is preferred; or
- •iii. Metastatic Breast Cancer: As monotherapy in patients resistant to both paclitaxel and
- •an anthracycline containing regimen
- •3. Patients already receiving a stable twice-daily dosing regimen of capecitabine (i.e. 1250
- •mg/m2, twice daily, equivalent to 2500 mg/m2 total daily dose, for two-weeks followed by a
- •one-week rest period given as three-week cycles).
- •4. Patients with Body Mass Index (BMI) between 17 kg/m2 and 30 kg/m2.
- •5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
- •6. Patients with life expectancy of at least 3 months.
- •7. Patients should be non-smokers.
- •8. Patients should be able to comply with protocol requirements and assessments.
- •9. Patients willing to provide written informed consent for participation in the study.
排除标准
- •1. Patients with known hypersensitivity to capecitabine or to any of its components of
- •formulation or 5-fluorouracil
- •2. Use of oral-coumarin derivative anticoagulants such as warfarin or phenprocoumon within 3
- •months prior to randomization or patients who may require these drugs within 1 month after
- •completion of the study.
- •3. Patients receiving concomitant therapy of Phenytoin, Leucovorin, and CYP2C9 substrates or
- •need to receive these medications within one month after last dose of receiving the study drug.
- •4. Known history of dihydropyrimidine dehydrogenase (DPD) deficiency
- •5. Patients with the following abnormal laboratory parameters:
- •6. Hemoglobin 9.0 g/dL.
- •7. Absolute Neutrophil Count (ANC) 1.5 x 109 /L.
- •8. Platelet count 100,000/μL.
- •9. Serum bilirubin 2 times the upper limit of normal
- •10. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2.5 times of upper
- •normal limit
- •11. Creatinine clearance according to Cockcroft-Gault Equation <= 50 mL/min
- •12. Patients with known brain metastasis and/or pre-existing motor or sensory neurotoxicity of
- •severity >=2 by National Cancer Institute Common Terminology Criteria for Adverse Event
- •(NCI CTCAE) criteria.
- •13. Consumption of grapefruit, grapefruit-like or grapefruit containing products within 7 days prior
- •to study drug administration.
- •14. Ingestion of any alcoholic, caffeine or xanthine containing food or beverage within the 48
- •hours prior to study drug administration.
- •15. Use of enzyme modifying drugs within 30 days prior to study drug administration. They can be
- •allowed depending on Principal Investigatorâ??s discretion in consultation with medical monitor,
- •if they are kept constant in the last 30 days and are expected to remain constant during the
- •study period.
- •16. Major surgery to the gastrointestinal tract, liver or kidney within 3 months prior to study entry
- •which may affect the pharmacokinetics of capecitabine.
- •17. 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.
- •18. History or presence of cardiac disease including myocardial infarction, unstable angina,
- •coronary artery disease, heart failure, dysrhythmias, cardiomyopathy, significant pericardial
- •disease or any other cardiac illness that could affect patient safety.
- •19. Electrocardiographic evidence of acute ischemic or active conduction system abnormalities
- •20. History or evidence of uncontrolled coagulopathy
- •21. Patients with severe hepatic or renal impairment
- •22. History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to
- •venepuncture or patients who have bled more than 300 mL in the past 3 months
- •23. Participation in any clinical trial of investigational drugs or devices in the past 3 months
- •24. Any significant disease or condition of haemopoeitic, gastrointestinal, renal, hepatic,
- •cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body
- •system which might compromise patient safety or affect study results.
- •25. Patients with history of alcoholism, or
研究者
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