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Bioequivalence study of Capecitabine 500 mg with XelodaÂ(capecitabine) tablets 500 mg in Locally Advanced Breast Cancer or Metastatic Breast Cancer or Colorectal Cancer patients under fed condition


ABSTRACT: Intervention1: Capecitabine Tablets 500mg: Capecitabine Tablets 500 mg will be administered as a single oral dose as multiples of 500mg on Day 1 and Day 2 morning dose as per randomization schedule. Control Intervention1: Xeloda tablet 500mg: Capecitabine Tablets 500 mg will be administered as a single oral dose as multiples of 500mg on Day 1 and Day 2 morning dose as per randomization schedule. Primary outcome(s): To characterise the pharmacokinetic profile of the sponsors test formulation [Capecitabine Tablets 500 mg] relative to that of reference formulation [Xeloda Tablets 500 mg] in patients with Metastatic Breast Cancer or Colorectal Cancer under fed condition and to assess the bioequivalence.Timepoint: The venous blood samples will be withdrawn Pre-dose and 0.25(15 min), 0.5(30 min), 1, 1.333, 1.667, 2, 2.333, 2.667, 3, 3.5, 4, 5, 6, 8, 10 hr post-dose in each period administration

DISEASE(S): Malignant Neoplasm Of Breast Of Unspecified Site

PROVIDER: 2573902 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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