To test the similarity of two formulation of Capecitabine in Metastatic Breast Cancer or Colorectal Cancer patients

ABSTRACT: 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

DISEASE(S): Malignant Neoplasm Of Colon, Unspecified

PROVIDER: 2572876 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR