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A comparative study of Capecitabine Capsules 500 mg and Capecitabine tablet 500 mg in patients of breast, colon or rectal cancer

ABSTRACT: Intervention1: Capecitabine Extended Release Capsules 500 mg of Intas Pharmaceuticals Limited, India: Dose: 1250 mg/m2; Frequency: twice daily; Mode of Administration: Per oral; Duration of treatment: 1 week Control Intervention1: Capecitabine film coated tablets 500 mg of Accord healthcare Inc, USA: Dose: 1250 mg/m2; Frequency: twice daily; Mode of Administration: Per oral; Duration of treatment: 1 week Primary outcome(s): To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsors formulation- Capecitabine Extended Release Capsules 500 mg (Test drug, Intas Pharmaceuticals Ltd., India) with Capecitabine) film coated Tablets 500 mg (Reference drug, Intas Pharmaceuticals Ltd., IndiaTimepoint: Pre-dose (Day01, Day 05 to Day 07 and Day 08 Day 12 to Day 14) Post-dose on Day 07 and Day 14

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

PROVIDER: 2582199 | 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: Patients will be on an overnight fast for at least 10 hours prior to serving of a high-fat, high-calorie breakfast (approximately 800 to 1000 kilocalories) on the day of dosing. This meal should derive approximately 150, 250, and 500-600 kilocalories from protein, carbohydrate, and fat, respectively. Patients will be required to consume completely within 30 minutes prior to dosing in each period Information on the amount of meal left and the time taken for consuming the meal will be recorded in the appropriate source notes. The actual time of meal distribution will also be recorded. Capecitabine should be administered along with 150 mL of water within 30 minutes of serving the breakfast. On the morning of dosing, upto 250 ml of water may be permitted up to 2 hours before drug administration. 2 hours after drug administration, 250 ml of Xanthine-free fluids are permitted. No food should be allowed for at least 4 hours post-dose. Intervention2: Capecitabine Tablets USP 500 mg Each film -coated tablet contains: Capecitabine USP 500 mg Manufactured by: Intas Pharmaceuticals limited, India : Patients will be on an overnight fast for at least 10 hours prior to serving of a high-fat, high-calorie breakfast (approximately 800 to 1000 kilocalories) on the day of dosing. This meal should derive approximately 150, 250, and 500-600 kilocalories from protein, carbohydrate, and fat, respectively. Patients will be required to consume completely within 30 minutes prior to dosing in each period Information on the amount of meal left and the time taken for consuming the meal will be recorded in the appropriate source notes. The actual time of meal distribution will also be recorded. Capecitabine should be administered along w Primary outcome(s): To characterize the pharmacokinetic profile of the sponsors test formulation [Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals limited, India)] relative to that of reference formulation [Xeloda (capecitabine) Tablets 500 mg (Distributed by: Hoffmann-La Roche Limited., Mississauga ON L5N 6L7, Canada)] in patients of Metastatic Breast Cancer or Colorectal Cancer under fed condition and to assess the bioequivalenceTimepoint: 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

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A comparative study of Capecitabine Capsules 500 mg and Capecitabine tablet 500 mg in patients of breast, colon or rectal cancer

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