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临床试验/CTRI/2013/08/003922
CTRI/2013/08/003922已完成未知

A RANDOMIZED, TWO TREATMENT, FOUR PERIOD, TWO SEQUENCE, SINGLE DOSE, REPLICATED CROSSOVER, BIOEQUIVALENCE STUDY OF CAPECITABINE 500 MGTABLETS OF SUN PHARMACEUTICAL INDUSTRIES LIMITED INDIA AND PrXELODA® (CAPECITABINE) 500 MG TABLETS OF HOFFMANN-LA ROCHE LIMITED, IN CANCER PATIENTS UNDER FED CONDITIONS

Sun Pharmaceutical Industries Ltd0 个研究点目标入组 30 人开始时间: 待定最近更新:
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试验速览

阶段
未知
状态
已完成
入组人数
30
研究概览入排标准研究者记录与标识符相似试验

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

  • •Subjects meeting all of the following criteria will be considered for enrollment in the study:
  • •i. Availability of subject for the entire study period and willingness to adhere to protocol
  • •requirements.
  • •ii. Subjects between 18 to 60 years of age (both inclusive).
  • •iii. Subjects who have no evidence of underlying disease which in the judgment of the
  • •investigator would not make the subject inappropriate for getting enrolled in the study
  • •(except Dukesâ?? C colon cancer/ metastatic colorectal carcinoma/ metastatic breast cancer)
  • •during screening, medical history and whose physical examination is performed within 21
  • •days prior to commencement of the study.
  • •iv. Patients who are taking Capecitabine as a single agent for adjuvant treatment for Dukesâ?? C
  • •colon cancer who have undergone complete resection of the primary tumor when treatment
  • •with fluoropyrimidine therapy alone is preferred.
  • •v. Patients who are taking Capecitabine as first-line treatment for metastatic colorectal
  • •carcinoma when treatment with fluoropyrimidine therapy alone is preferred.
  • •vi. Patients who are taking Capecitabine for the treatment of metastatic breast cancer resistant to
  • •both paclitaxel and an anthracycline containing chemotherapy regimen or resistant to
  • •paclitaxel and for whom further anthracycline therapy is not indicated, eg, patients who have
  • •received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents. (Only
  • •capecitabine as chemotherapeutic agent).
  • •vii. Patients should not take any adjuvant chemotherapeutic agent except capecitabine throughout
  • •the study and 4 weeks before the study.
  • •viii. Patients whose life expectancy of greater than or equal to 6 months.
  • •ix. Patients having histologically proven Cancer.
  • •x. Patients with Performance <= 2 on the ECOG performance scale .
  • •xi. Subjects whose screening laboratory values are within normal limits or considered by the
  • •Investigator/sub-Investigator to be of no clinical significance.
  • •xii.The subject must sign the written consent form (subject
  • •Information and Consent Form) prior to study entry.
  • •xiii. Female Subjects of
  • •child bearing potential practicing an acceptable method of birth control for the duration
  • •of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm,
  • •intrauterine device (IUD), or abstinence.
  • •Postmenopausal for at least 1 year.
  • •Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has
  • •been performed on the subject).

排除标准

  • •1. History or presence of significant:
  • •i. Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Capecitabine
  • •and/or any related compounds etc.
  • •ii. Hepatic impairment, renal (including severe renal impairment), hematological (including
  • •leucopenia, thrombocytopenia), endocrine, immunologic, dermatologic, musculoskeletal,
  • •neurological, or psychiatric disease which has an impact on subject safety and does not permit
  • •dosing of capecitabine.
  • •iii. Patient having cardiovascular (including coronary artery disease) & pulmonary disorder.
  • •iv. Cancer patients with a prior history of coronary artery disease, receiving concomitant therapy of
  • •v. Presence of infections which reduce life expectancy.
  • •vi. Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within
  • •past one year.
  • •vii. Patient having clinical evidence of brain metastasis.
  • •viii. Undergoing concomitant oncologic treatment.
  • •ix. Smoking or consumption of tobacco products.
  • •x. History of difficulty in swallowing or coming for follow up.
  • •xi. Clinically significant illness (except Dukesâ?? C colon cancer/metastatic colorectal
  • •carcinoma/metastatic breast cancer) within 4 weeks before the start of the study.
  • •xii. Subjects who have been on an abnormal diet (for whatever the reason) during the four weeks
  • •preceding the study.
  • •xiii. Female subject who is pregnant, lactating or likely to become pregnant or have a positive
  • •pregnancy test at screening and prior to check in.
  • •xiv. Positive result to HIV, HCV, RPR and HBsAg.
  • •xv. Use of enzyme-modifying drugs (like Phenytoin, Fosphenytoin, Carbamazepine, Barbiturates,
  • •Gresiofulvine etc.) in the previous 30 days before day 1 of this study.
  • •xvi. Abnormal 12 lead ECG, X-ray
  • •2. Donation of blood in the previous 90 days before day 1 of this study
  • •3. Participation in another clinical trial within the preceding 90 days of study starts.
  • •4. Subjects who have:
  • •i. Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
  • •ii. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor
  • •deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the investigator.
  • •iii. Pulse rate below 60/min. or above 100/min.

研究者

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