A bioequivalence study of Capecitabine tablets in patients of Locally Advanced or Metastatic Breast Cancer or Metastatic Colorectal Cancer

Intervention1: Capecitabine tablets 500 mg: In the current study, patients will be administered 3 tablets of Capecitabine 500 mg (Test Product or Reference Product) as the morning dose on first day of each period. The evening dose on Day 1 and next 13 days dosing will be as per the discretion of the investigator
Control Intervention1: XELODA® 500 mg tablets: In the current study, patients will be administered 3 tablets of Capecitabine 500 mg (Test Product or Reference Product) as the morning dose on first day of each period. The evening dose on Day 1 and next 13 days dosing will be as per the discretion of the investigator.
Primary outcome(s): To characterise the pharmacokinetic profile of the sponsor?s test formulation (Capecitabine Tablets 500 mg, Manufactured by Intas Pharmaceutical Ltd., India) relative to that of reference formulation (XELODAÂ 500 mg tablets, Manufactured by Roche Pharma AG, Germany) in patients of Locally Advanced or Metastatic Breast Cancer or Metastatic Colorectal Cancer under fed condition and to assess the bioequivalence.Timepoint: NIL
Study Design: Randomized, Crossover Trial
Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label