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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 Control Intervention1: XelodaÂ (Capecitabine) 500mg film coated tablet, manufactured by Roche Pharma AG, Emil-Barell Str I, D-79639 Grenzach-Wyhlen, Duitsland: The recommended dose of XELODAÂ 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): Advanced Or Metastatic Breast Cancer Or Colorectal Cancer Or Advanced Gastric Cancer

PROVIDER: 2573796 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Intervention1: Capecitabine Tablets USP 500 mg Each film -coated tablet contains: Capecitabine USP 500 mg Manufactured by: Intas Pharmaceuticals Ltd, India. : The recommended dose of XELODAÂ 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. In current study, Test and Reference formulation of Capecitabine Tablets USP 500 mg will be administered as a single dose as multiples of 500mg on Day 1 and Day 2 morning dose as per randomization schedule. The evening dose on day 1 and day 2 will be locally approved and marketed capecitabine Tablets 500 mg. Locally approved and marketed Capecitabine will also be provided for the remaining treatment cycle/s. Control Intervention1: XelodaÂ (capecitabine) Tablets 500 mg Each tablet contains: Capecitabine 500 mg Distributed by: Roche Chemical and Pharmaceutical Products SA, Brazil : The recommended dose of XELODAÂ 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. In current study, Test and Reference formulation of Capecitabine Tablets USP 500 mg will be administered as a single dose as multiples of 500mg on Day 1 and Day 2 morning dose as per randomization schedule. The evening dose on day 1 and day 2 will be locally approved and marketed capecitabine Tablets 500 mg. Locally approved and marketed Capecitabine will also be provided for the remaining treatment cycle/s. Primary outcome(s): To characterise the pharmacokinetic profile of the sponsors test formulation [Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals Ltd, India)] relative to that of reference formulation [XelodaÂ(capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., Brazil)] in patients of Metastatic Breast Cancer or Colorectal Cancer under fed condition and to assess the bioequivalence.Timepoint: NIL Study Design: Randomized, Crossover Trial Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label

Project description:Intervention1: Capecitabine Tablets USP 500 mg: Each film -coated tablet contains: Capecitabine USP 500 mg Manufactured by: Dr. Reddys Laboratories, India The recommended dose of XELODAÂ 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. In current study, Test and Reference formulation of Capecitabine Tablets USP 500 mg will be administered as a single dose as multiples of 500mg on Day 1 and Day 2 morning dose as per randomization schedule. The evening dose on day 1 and day 2 will be reference listed drug XelodaÂ (capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., New Jersey 07110) and doses for the remainder treatment cycle will be locally approved and marketed drug. The morning and evening dose will be based on BSA. The BSA will be calculated for the patient 12 hours prior to dosing on Day 1 and the same will be used for the dosing on Day 2 as well. Control Intervention1: XelodaÂ (capecitabine) Tablets 500 mg: Each tablet contains: Capecitabine 500 mg Distributed by: Roche Laboratories Inc., New Jersey 07110-1199 The recommended dose of XELODAÂ 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. In current study, Test and Reference formulation of Capecitabine Tablets USP 500 mg will be administered as a single dose as multiples of 500mg on Day 1 and Day 2 morning dose as per randomization schedule. The evening dose on day 1 and day 2 will be reference listed drug XelodaÂ (capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., New Jersey 07110) and doses for the r Primary outcome(s): To characterise the pharmacokinetic profile of the sponsors test formulation (Capecitabine Tablets 500 mg, Manufactured by Dr. Reddys Laboratories, India) relative to that of reference formulation (XELODAÂ 500 mg tablets, Distributed by Roche Laboratories Inc., USA) in patients of Metastatic Breast Cancer or Colorectal Cancer under fed condition and to assess the bioequivalence.Timepoint: NIL Study Design: Randomized, Crossover Trial Method of generating randomization sequence:Other Method of allocation concealment:Centralized Blinding and masking:Open Label

Dataset Information

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

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