A Multicentre, Randomized, Open Label, Two-Period, Two-Treatment,Two-Way Crossover, Comparative Bioavailability Study At Steady StateComparing Capecitabine Extended Release Capsule 500 mg (IntasPharmaceuticals Ltd., India) To The Reference Listed Drug XelodaÂ®(Capecitabine 500 mg; Roche Pharmaceuticals) In Patients Of BreastCancer Or Colorectal Cancer Under Fed Condition - NA

Intas Pharmaceuticals Ltd0 个研究点目标入组 24 人开始时间: 待定最近更新: 2021年11月24日

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•1. Male or Female >=18 to <= 65 years of age and having a Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m2
•2. Patients must have/have had histopathologically /cytologically confirmed breast cancer or colorectal cancer.
•3.Patients with
•a. Metastatic colorectal carcinoma when treatment with fluoro pyrimidine therapy alone is preferred.
•b. Metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen
•4. Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
•5. Patient with adequate bone marrow, renal and hepatic function.
•6. Adequate Cardiac function (left ventricular ejection fraction[LVEF] >=50%)
•7. Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator
•8. Able to comply with study requirement in opinion of Principal Investigator.
•9. Able to give written informed consent for participation in the trial.

•1.Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency.
•2. Pregnant or breast-feeding female
•3. History of drug/alcohol addiction
•4. Known brain metastasis
•5. Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 by NCI CTCAE criteria.
•6. A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies
•7. Known case of HIV infection.
•8. Any other condition that, in the investigatorâ??s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.

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