A study comparing capecitabine oral granules 500 mg per packet to capecitabine tablets 500 mg in patients with breast cancer or colorectal cancer

Intervention1: Capecitabine oral granules 500 mg per packet of Intas Pharmaceuticals Limited, India: Dose: single dose as multiples of 500 mg ; Frequency: single dose on day 1, day 2 and day 3 ; Mode of Administration: oral ; Duration of treatment: 3 days
Control Intervention1: Xeloda (capecitabine) tablets 500 mg, Distributed by: Genentech USA, Inc., A member of the Roche group: Dose: single dose as multiples of 500 mg ; Frequency: single dose on day 1, day 2 and day 3 ; Mode of Administration: oral ; Duration of treatment: 3 days
Primary outcome(s): To characterise the pharmacokinetic profile of the sponsors test formulation
[capecitabine oral granules 500 mg per packet (Manufactured by Intas Pharmaceuticals Ltd, India)] relative to that of reference formulation [Xeloda (capecitabine) tablets 500 mg (Distributed by: Genentech USA, Inc., A member of the Roche group, 1 DNA Way, South san Francisco, CA 94080-4990)] in patients of metastatic breast cancer or metastatic colorectal cancer under fed condition and to assess the bioequivalence.Timepoint: Pre-dose and 0.167, 0.333,
0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.250, 2.500, 2.750, 3.000, 3.333,
3.667, 4.000, 4.500, 5.000, 6.000, 7.000 and 8.000 hour post-dose