An open label, multicenter, balanced, randomized, two treatment, twosequence four period, full replicate, crossover, single dose, comparative oral bioavailability study in adult human cancer patients.

INTERVENTION: Intervention1: Capecitabine Tablets 1000 mg of Shilpa Medicare Limited, India: As per the randomization schedule, test product will be administered orally to each patient in the morning on Day 01 (Period 01), Day 02 (Period 02), Day 03 (Period 03) and Day 04 (Period 04). Control Intervention1: Xeloda Tablets 500 mg of MAH CHEPLAPHARM Arzneimittel GMBh Ziegelhof 2417489 Greifswald Germany: As per the randomization schedule, reference product will be administered orally to each patient in the morning on Day 01 (Period 01), Day 02 (Period 02), Day 03 (Period 03) and Day 04 (Period 04). CONDITION: Health Condition 1: C509‐ Malignant neoplasm of breast of unspecified site Health Condition 2: C189‐ Malignant neoplasm of colon, unspecified Health Condition 3: C20‐ Malignant neoplasm of rectum PRIMARY OUTCOME: To compare the bioavailability of Capecitabine Tablets 1000 mg of Shilpa Medicare Limited, India with Xeloda 500mg Film‐Coated Tablets Capecitabine marketed by MAH CHEPLAPHARM Arzneimittel GMBh Ziegelhof 24 17489 Greifswald Germany at a dose of 2000 mg in adult human cancer patients under fed conditionsTimepoint: 00.00 hour, 00.08, 00.17, 00.33, 00.50, 00.67, 01.00, 01.25, 01.50, 01.75, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 05.00, 06.00 and 08.00 hours after morning dose in each period SECONDARY OUTCOME: To monitor the adverse events and to ensure the safety of patientsTimepoint: Blood samples will be collected at pre‐dose 00.00 hour, within 10 minutes and at 00.08, 00.17, 00.33, 00.50, 00.67, 01.00, 01.25, 01.50, 01.75, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 05.00, 06.00 and 08.00 hours after morning dose in each period INCLUSION CRITERIA: 1. Willing and able to provide voluntary informed consent and able to comply with protocol requirements 2. Male or female subjects aged 18 to 65 years both inclusive having body mass inde Xat least 18.5 to 29.9 kg per m2 3. Patients having body surface area between 1.27 to 1.92 m2 both inclusive measured as per dubois formula 4. Patients with histopathologically or cytologically confirmed colon or colorectal or breast cancer 5. Patients with Dukes C colon cancer who have undergone complete resection of the primary tumor and when treatment with fluoropyrimidine therapy alone is preferred Or Patients with metastatic colorectal carcinoma in whom treatment with fluoropyrimidine therapy alone is preferred Or Patients with locally advanced or metastatic breast cancer, after failure of taxanes and an anthracycline‐containing chemotherapy regimen or for whom further anthracycline therapy is not