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Bioequivalence study to compare Xeloda and Capecitabine tablets in patients with colorectal cancer or breast cancer

ABSTRACT: Intervention1: Capecitabine (CJSC Biocad) tablets 500mg: The study will involve patients who receive capecitabine monotherapy. In a monotherapy regimen, capecitabine is administered 1250 mg/m2 twice a day in the morning and evening (total daily dose of 2500 mg/m2) for two weeks followed by 7 days break. Within this study, Capecitabine will be administered orally in the morning of Day 1/Day 2 in the dose of 1250 mg/m2. The drug will be taken within 30 minutes after the meal (breakfast). Control Intervention1: Xeloda (Capecitabine)tablets 500mg: The study will involve patients who receive capecitabine monotherapy. In a monotherapy regimen, capecitabine is administered 1250 mg/m2 twice a day in the morning and evening (total daily dose of 2500 mg/m2) for two weeks followed by 7 days break. Within this study, Xeloda will be administered orally in the morning of Day 1/Day 2 in the dose of 1250 mg/m2. The drug will be taken within 30 minutes after the meal (breakfast). Primary outcome(s): Assessment of pharmacokinetic parameters after single administration of the Test drug and the reference drug: Area under capecitabine Â«concentration-timeÂ» curve at the time of the drug administration up to 12 hours (AUC(0-12)) Timepoint: 0 min, 15 mins, 30 mins, 45 mins, 1hr, 1hr 30 mins, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 10 hrs and 12 hrs after administration of the test or reference drug. Study Design: Randomized, Crossover Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label

DISEASE(S): Patients With Colorectal Cancer Or Breast Cancer

PROVIDER: 2574596 | 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: 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

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

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Bioequivalence study to compare Xeloda and Capecitabine tablets in patients with colorectal cancer or breast cancer

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