Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
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
Sponsors
Dr Reddys Laboratories Hyderabad India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female 18-79 years of age (both inclusive) and having a Body Mass Index (BMI) in between 18.5 and 30 calculated as weight in kg / height in m2 2. Patients must have/have had histopathologically /cytologically confirmed breast cancer or colorectal cancer. 3. Adjuvant treatment for Patients following surgery of stage III (Dukesâ?? stage C) colon cancer. Or Patients with metastatic colorectal cancer 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 indicated. 4. Patients who require a daily dose of Capecitabine monotherapy, who are stabilized on twice daily dosing at a dose of 1250 mg/m2 and who have completed at least one cycle of chemotherapy 5. Patients should have their BSA (as per the DuBois formula) between 1.26-1.91 m2 (Both inclusive). Note : Dosage and administration of Capecitabine will be as per instructions given in section 1.7 Dosage and administration. 6. Eastern Cooperative Oncology Group (ECOG) performance status <= 2
Exclusion criteria
Exclusion criteria: Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency. Pregnant or breast-feeding female Any other condition that, in the investigator?s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study. Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study. Known, existing uncontrolled coagulopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterise the pharmacokinetic profile of the sponsorâ??s test formulation (Capecitabine Tablets 500 mg, Manufactured by Dr. Reddyâ??s Laboratories, India) relative to that ofreference formulation (XELODA® 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the patients, who are exposed to the Investigational Medicinal ProductTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Praveen Shetty
NIL
Outcome results
None listed