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 PrXeloda (Capecitabine) 500 mg Tablets of Hoffmann-La Roche Limited, in cancer patients under fed conditions.

Intervention1: Capecitabine 500 mg Tablet of Sun
Pharmaceutical Industries Limited, India
: Single Oral Dose
Control Intervention1: PrXeloda (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