CTRI/2011/11/002171已完成3 期
Single-Dose Fed Bioequivalence Study of Capecitabine Tablets (500 mg; Mylan) to Xeloda® Tablets (500 mg; Genentech) in Adult Cancer Patients with Metastatic Breast Cancer, Dukeâ??s C Colon Cancer or Metastatic Colorectal Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 42
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.Volunteers must be receiving stable doses of capecitabine (e.g. 2500 mg/m2/day in two divided dose) for the treatment of metastatic breast cancer (in combination with docetaxel), Dukesâ?? C colon cancer following complete resection, and metastatic colorectal carcinoma in combination with capecitabine (e.g. 2500 mg/m2/day in two divided doses).
- •a.Patients must have completed at least one 21-day cycle of capecitabine (i.e. 14 days of capecitabine and 7 days washout) at the dose to be utilized in this study.
- •b.The dose of capecitabine must be administered as a multiple of the intact, unbroken, 500 mg tablet.
- •2.Cancer patients with monotherapy are preferred. However, cancer patients receiving concomitant drug(s) are allowed to participate, provided:
- •a.The concomitant medication is the same during all study days. Each concurrent medication will be documented and clearly identified. Information recorded will include at least the following information: generic name, strength, dosing regimen, and time of dosing.
- •b.The subjects will follow the same dosing regimen for the concurrent medications for all dosing of the bioequivalent study.
- •c.Patients will not change their concurrent medications during the BE study.
- •d.Prior to inclusion of the subject into the study, a list of all concurrent medications will be provided to the sponsor for approval.
- •1.3.Age:18 â?? 80 years of age (inclusive)
- •2.4.Sex:Females of non-childbearing potential and Males (with equal numbers of each sex, if possible).
- •a.Women 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 (1) 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.
- •b.Non-lactating (or not nursing)
- •5.Capable of informed consent.
- •6.Weight Restrictions:
- •a.At least 50 kg (110 lbs) for men and
- •b.At least 48 kg (106 lbs) for women
- •c.All subjects will have a Body Mass Index (BMI) less than or equal to 35 but greater than or equal to 19. BMI values should be rounded to the nearest integer (ex. 35.4 rounds down to 35, while 18.5 rounds up to 19).
- •7.Tobacco Use: Non-smokers to moderate-smokers ( < 20 cigarettes per day) will be eligible to participate in this study.
- •8.All subjects should be judged by the principal or Medical Sub-Investigator physician listed on the Form FDA 1572 as normal and healthy during a pre-study medical evaluation performed within 28 days of the initial dose of study medication which will include:
- •a.Normal or non-clinically significant physical examination including vital signs (respiration rate, blood pressure, temperature and heart rate).
- •b.Within normal limits or non-clinically significant laboratory evaluation results, (unless otherwise noted in the exclusion criteria), for the following tests:
- •i.Serum Chemistries
- •ii.Hematology
- •iii.Urinalysis
- •c.negative Hepatitis B and Hepatitis C tests,
- •d.negative HIV test,
- •e.INR within normal range
- •f.normal or non-clinically significant 12-lead ECG
- •g.negative urine drug screen for all of the following compounds: amphetamin
排除标准
- •Subject candidates must not be enrolled in the study if they meet any of the following criteria:
- •1.Institutionalized subjects will not be used.
- •2.Individuals with dihydropyrimidine dehydrogenase (DPD) deficiency.
- •3.Individuals with rapidly progressing disease, especially with visceral organ involvement.
- •4.Individuals requiring a change in dose or regimen of either capecitabine or had their dosing regimen altered within the previous 21 days.
- •5.Social Habits:
- •a.Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
- •b.Ingestion of any vitamins, food, or herbal supplement known to induce or inhibit hepatic enzyme activity within 7 days prior to the initial dose of study medication. Especially those known to inhibit or induce CYP3A4.
- •6.Medications:
- •a.Use of warfarin currently or within the last 3 months.
- •b.Use of any prescription or over-the-counter (OTC) medications within the 24 hours prior to the initial dose of study medication, except for any necessary medication for which dosing has been stabilized for a period of at least 21 days and is expected to remain stable for the entire study.
- •c.Use of any medication known to induce or inhibit hepatic enzyme activity within 28 days prior to the initial dose of study medication except for any necessary medication for which dosing has been stabilized for a period of at least 28 days and is expected to remain stable for the entire study.
- •7.Diseases:
- •a.History of unstable or clinically significant gastrointestinal disease, including a history of chronic diarrhea, inflammatory bowel disease, unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting). History of difficulties in swallowing.
- •b.ALT and AST greater than 2.5 times the upper limit of normal and/or total bilirubin greater than 2.5 times the upper limit of normal.
- •c.Patients with significant hepatic or renal dysfunction, or for whom the need for dose changes during the study can be anticipated.
- •d.Patients with a prolonged QT
- •e.Known history of prior tuberculosis infection, or any contact within the past 2 years with person with active tuberculosis.
- •f.History of moderate (30-50 mL/min creatinine clearance) or severe (<= 30 mL/min creatinine clearance) renal disease.
- •g.History of unstable or clinically significant cardiovascular disease, hepatic, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic (including any history of seizure disorder), psychological, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator or Medical Sub-Investigator.
- •h.Acute illness at the time of either the pre-study medical evaluation or dosing.
- •8.Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the subject form safely participating in the study.
- •9.Donation or loss of blood or plasma: 50 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication.
- •10.Intolerance to venipuncture.
- •11.Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- •12.History of allergy or hypersensitivity to capeci
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