A multicentre, randomized, open-label, single dose, two-treatment, three-period, three-sequence, partial replicate, crossover, pivotal bioequivalence study of Test capecitabine 500 mg tablet manufactured by Reliance Life Sciences Pvt. Ltd., India with XelodaÂ® (capecitabine 500 mg) manufactured by Roche Pharma AG, Germany in adult, human, cancer patients under fed condition.

Reliance Life Sciences Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Males or females 18 to 65 years of age.
•2.Patients with Body Mass Index (BMI) between 17 kg/m2 and 30 kg/m2.
•3.Patients in whom capecitabine is indicated as adjuvant treatment following surgery of stage III (Dukesâ?? stage C) colon cancer
•Patients with metastatic colorectal cancer
•Patients with locally-advanced or metastatic breast cancer
•4.Cancer patients who are already receiving stable twice-daily dosing regimen of capecitabine as monotherapy as prescribed by treating physician.
•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 willing to voluntarily provide written informed consent or consent from a Legally Acceptable Representative (LAR), if the patient is not in a condition to give consent.

•Exclusion Criteria
•1.Patients with inadequate venous access to allow the collection of all samples via venous cannula in the study.
•2.Pregnant (female patients with a positive serum pregnancy test at screening or positive urine pregnancy test before period I of hospitalization) or lactating females
•3.Patients with the following abnormal laboratory parameters:
•4.Patients with a known hypersensitivity to fluoropyrimidine therapy or known sensitivity to 5- fluorouracil, receiving concomitant therapy of warfarin,or known Dihydropyrimidine dehydrogenase (DPD) deficiency.
•5.Patients with known brain metastasis
•6.History or evidence of uncontrolled coagulopathy.
•7.History of hereditary galactose/ glucose/ lactase disorders.
•8.History or evidence of cardiac disease
•9.Patients with a history of alcoholism, or drug abuse
•10.Patients diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
•11.Patients having an abnormal serum calcium level
•12.Patients who have participated in any other clinical investigation using experimental drugs
•13.Patients with hepatic impairment and severe renal impairment.
•14.Any other condition which the investigator feels would pose a significant hazard to the patient if capecitabine is administered.

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