Dataset Information

To monitor the safety of the subjects participating in the study and to assess the bioequivalence of Capecitabine 500 mg Tablets of Sun Pharmaceutical Industries Limited, India and PrXelodaÂ (Capecitabine) 500 mg Tablets of Hoffmann-La Roche Limited, in cancer patients under fed conditions.

ABSTRACT: Intervention1: Capecitabine 500 mg Tablet of Sun Pharmaceutical Industries Limited, India : Single Oral Dose Control Intervention1: PrXelodaÂ (Capecitabine) 500 mg Tablet of Hoffmann-La Roche Limited, 2455 Meadowpine Blvd, Mississauga, Ontario, L5N 6L7 : Single Oral Dose Primary outcome(s): 1) To characterize the rate and extent of bioavailability of the test products in comparison with the reference product after single dose Administration under fed conditions. 2) Monitor the safety of the subjects participating in the study and the tolerability of the test products in comparison with the reference Considering adverse events. Timepoint: Pre Dose samples: 6 ml will be collected within 1.0 hour Prior to morning dosing. Post Dose samples: The post-dose blood samples (1 x 2 mL each) will be collected at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.167, 1.333, 1.500, 1.667, 1.833, 2.000, 2.250, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000 and 6.000 hours after administration of Morning dose. Study Design: Randomized, Crossover Trial Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Centralized Blinding and masking:Open Label

DISEASE(S): Dukesâ?? C Colon Cancer, Metastatic Colorectal Carcinoma, Metastatic Breast Cancer

PROVIDER: 2574844 | 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

Dataset Information

To monitor the safety of the subjects participating in the study and to assess the bioequivalence of Capecitabine 500 mg Tablets of Sun Pharmaceutical Industries Limited, India and PrXelodaÂ (Capecitabine) 500 mg Tablets of Hoffmann-La Roche Limited, in cancer patients under fed conditions.

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