Clinical

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To assess the safety and tolerability of a single oral dose of the Capecitabine test and reference formulations


ABSTRACT: Intervention1: Capecitabine Tablets 500 mg, manufactured by Hetero labs ltd.: The recommended dose of capacitabine is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles Intervention2: Capecitabine Tablets 500 mg,manufactured by Hetero labs ltd.: The recommended dose of capacitabine is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles Control Intervention1: Xeloda (Capecitabine) Tablets 500 mg (Distributed by Genentech USA, Inc., A Member of the Roche Group, South San Francisco, CA 94080): The recommended dose of XELODA is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles Primary outcome(s): Establishing the bioequivalence between test and referenceTimepoint: Day 1 and Day 2

DISEASE(S): Locally Advanced Or Metastatic Breast Cancer Or Colorectal Cancer Adult Subjects

PROVIDER: 2573933 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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2023-11-21 | PXD040451 | Pride