A clinical trial to study the bioequivlence study of Capeciatabine in Locally Advanced Breast Cancer or Metastatic Breast Cancer or Colorectal Cancer patients under fed condition

Intervention1: Capecitabine Tablets USP 500 mg: The recommended dose of Capecitabine 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
Control Intervention1: Xeloda® (capecitabine) Tablets 500 mg: The recommended dose of XELODA® 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
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 ofreference formulation (XELODAÂ 500 mg tablets, Manufacturedby Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom) in patients of Locally Advanced or 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