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This is a comperative study of Capecitabine Capsule 500 mg tablets manufactured by sponsor with Xeloda 500 mg Tablets of Genetech USA, A Member of Roche group, USA, in adult patients with Breast cancer and Colorectal cancer under fed condition.

ABSTRACT: Intervention1: Capecitabine Capsule 500 mg Tablets: Dose: 2500 MG/m2/Day for 14 days Duration : 1 cycle Frequency : 14 days with 7 days rest period. Mode of Admin: oral Control Intervention1: Capecitabine Capsule 500 mg Tablets: Dose: 2500 MG/m2/Day for 14 days Duration : 1 cycle Frequency : 14 days with 7 days rest period. Mode of Admin: oral Primary outcome(s): To compare and evaluate the single-dose oral bioavailability of Capecitabine Tablets, USP 500mg manufactured by Amneal Pharmaceuticals, USA with Â (capecitabine) Tablets 500mg distributed by Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990, following a single oral 2000mg (4x500mg) dose administration in adult human patients with cancer under fed condition.Timepoint: 0.17, 0.33, 0.50, 0.67, Pre, dose0.83, 1.00, 1.25, 1.50, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 7, and 8 following drug administration in each period.

DISEASE(S): Breast Cancer And Colorectal Cancer

PROVIDER: 2573649 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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