A multicentre, randomized, open label, two-period, two-treatment, two-way crossover,bioequivalence study comparing Capecitabine tablets 500 mg with XelodaÂ®(capecitabine) tablets 500 mg in Locally Advanced Breast Cancer or Metastatic BreastCancer or Colorectal Cancer patients under fed condition. Capecitabine is the test drug(Manufactured by: Jiangsu Hengrui Medicine Co.,China). Xeloda is the reference drug (Distributed by:Roche Registration Limited,UK)

Evenus Pharmaceutical Laboratories Inc0 个研究点目标入组 110 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.Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m2. 2.Patient with adequate bone marrow, renal and hepatic function. 3.Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator 4.Patients with life expectancy of at least 3 months (as per the
•Investigatorâ??s discretion) 5.Able to comply with study requirement in opinion of Principal
•Investigator 6.Able to give written informed consent for participation in the trial 7.Patients should have their BSA (as per the DuBois formula) between
•1.26-1.91 m2 (Both inclusive)

•1.Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine
•Dehydrogenase) deficiency. 2.History of drug/alcohol addiction. 3.Known brain metastasis 4.A positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies 5.Known HIV infection.6.History of drug/alcohol addiction. 7.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the
•first dose of investigational medicinal product for the current study.

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